FDA — authorised 26 July 1976
- Application: ANDA084578
- Marketing authorisation holder: LANNETT
- Local brand name: LANOPHYLLIN
- Indication: ELIXIR — ORAL
- Status: approved
🇺🇸 Aminophylline group in United States
FDA authorised Aminophylline group on 26 July 1976
Marketing authorisations
FDA — authorised 26 January 1979
- Application: ANDA085186
- Marketing authorisation holder: SOLIS PHARMS
- Local brand name: ELIXOPHYLLIN
- Indication: SOLUTION, ELIXIR — ORAL
- Status: approved
FDA — authorised 8 February 1979
- Application: ANDA085169
- Marketing authorisation holder: HALSEY
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 26 March 1979
- Application: ANDA086107
- Marketing authorisation holder: 3M
- Local brand name: THEOLAIR
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 May 1979
- Application: ANDA085187
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-PHYLLIN
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 13 July 1979
- Application: ANDA085263
- Marketing authorisation holder: KV PHARM
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 November 1979
- Application: ANDA085204
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-PHYLLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 1979
- Application: ANDA085202
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-PHYLLIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 January 1980
- Application: ANDA086748
- Marketing authorisation holder: WOCKHARDT
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 30 May 1980
- Application: ANDA086399
- Marketing authorisation holder: MEDICIS
- Local brand name: THEOLAIR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1980
- Application: ANDA086720
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 11 August 1980
- Application: ANDA085353
- Marketing authorisation holder: CENT PHARMS
- Local brand name: THEOCLEAR-200
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 November 1980
- Application: ANDA084726
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: THEOPHYL-225
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 1981
- Application: ANDA087194
- Marketing authorisation holder: GRAHAM DM
- Local brand name: SOMOPHYLLIN-CRT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 September 1981
- Application: ANDA087193
- Marketing authorisation holder: GRAHAM DM
- Local brand name: SOMOPHYLLIN-CRT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 October 1981
- Application: ANDA086485
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: THEOPHYL-225
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 15 April 1982
- Application: ANDA087679
- Marketing authorisation holder: CENCI
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 26 July 1982
- Application: NDA018649
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 January 1983
- Application: ANDA087400
- Marketing authorisation holder: NOSTRUM PHARMS LLC
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 June 1983
- Application: ANDA087563
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: QUIBRON-T/SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 17 August 1983
- Application: ANDA088253
- Marketing authorisation holder: PHARM RES ASSOC
- Local brand name: T-PHYL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 1983
- Application: ANDA087943
- Marketing authorisation holder: ENDO OPERATIONS
- Local brand name: THEO-24
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 November 1984
- Application: NDA019083
- Marketing authorisation holder: B BRAUN
- Local brand name: THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 November 1984
- Application: NDA019212
- Marketing authorisation holder: B BRAUN
- Local brand name: THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 December 1984
- Application: NDA019211
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 January 1985
- Application: ANDA087893
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-BID
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 January 1985
- Application: ANDA087892
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-BID
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 January 1985
- Application: ANDA087894
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-BID
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 January 1985
- Application: ANDA088269
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-BID
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 February 1985
- Application: ANDA086480
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: THEOPHYL-SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 February 1985
- Application: ANDA086471
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: THEOPHYL-SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 February 1985
- Application: ANDA088689
- Marketing authorisation holder: CENT PHARMS
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 1985
- Application: ANDA087854
- Marketing authorisation holder: WHITBY
- Local brand name: THEOBID JR.
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 1985
- Application: ANDA085983
- Marketing authorisation holder: WHITBY
- Local brand name: THEOBID
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 August 1985
- Application: ANDA088656
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: QUIBRON-T
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 1986
- Application: ANDA088255
- Marketing authorisation holder: SCHERER RP
- Local brand name: THEOPHYLLINE-SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 October 1986
- Application: ANDA084731
- Marketing authorisation holder: SCHERER RP
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 November 1986
- Application: ANDA085075
- Marketing authorisation holder: FLEMING PHARMS
- Local brand name: AEROLATE JR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 July 1987
- Application: ANDA088364
- Marketing authorisation holder: 3M
- Local brand name: THEOLAIR-SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 July 1987
- Application: ANDA089132
- Marketing authorisation holder: 3M
- Local brand name: THEOLAIR-SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 July 1987
- Application: ANDA088369
- Marketing authorisation holder: 3M
- Local brand name: THEOLAIR-SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 July 1987
- Application: ANDA086363
- Marketing authorisation holder: 3M
- Local brand name: THEOLAIR-SR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 October 1988
- Application: ANDA089626
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
FDA — authorised 24 April 1989
- Application: ANDA085545
- Marketing authorisation holder: FOREST LABS
- Local brand name: ELIXOPHYLLIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 October 1989
- Application: ANDA086545
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: THEOPHYLLINE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 30 April 1990
- Application: ANDA089807
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 April 1990
- Application: ANDA089808
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 April 1990
- Application: ANDA089763
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 November 1990
- Application: ANDA088382
- Marketing authorisation holder: GRAHAM DM
- Local brand name: SOMOPHYLLIN-CRT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 August 1992
- Application: NDA019826
- Marketing authorisation holder: B BRAUN
- Local brand name: THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 1992
- Application: ANDA081236
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 July 1993
- Application: ANDA086826
- Marketing authorisation holder: FOREST LABS
- Local brand name: ELIXOPHYLLIN SR
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 February 1994
- Application: ANDA040052
- Marketing authorisation holder: INWOOD LABS
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 January 1995
- Application: ANDA089823
- Marketing authorisation holder: SCHERING
- Local brand name: UNI-DUR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 January 1995
- Application: ANDA089822
- Marketing authorisation holder: SCHERING
- Local brand name: UNI-DUR
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 April 1995
- Application: ANDA040034
- Marketing authorisation holder: INWOOD LABS
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 April 1996
- Application: ANDA040086
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 March 1997
- Application: ANDA087763
- Marketing authorisation holder: GRAHAM DM
- Local brand name: SOMOPHYLLIN-CRT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 March 1997
- Application: ANDA088383
- Marketing authorisation holder: GRAHAM DM
- Local brand name: SOMOPHYLLIN-CRT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 April 2004
- Application: ANDA040539
- Marketing authorisation holder: ABLE
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 April 2004
- Application: ANDA040543
- Marketing authorisation holder: ABLE
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 April 2004
- Application: ANDA040546
- Marketing authorisation holder: ABLE
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 April 2004
- Application: ANDA040548
- Marketing authorisation holder: ABLE
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 April 2006
- Application: ANDA040560
- Marketing authorisation holder: MPP PHARMA
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 July 2010
- Application: ANDA090355
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 October 2010
- Application: ANDA090430
- Marketing authorisation holder: ALEMBIC
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 April 2011
- Application: ANDA091156
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: THEOPHYLLINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 15 June 2012
- Application: ANDA091586
- Marketing authorisation holder: TRIS PHARMA INC
- Local brand name: THEOPHYLLINE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 December 2016
- Application: ANDA206344
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: THEOPHYLLINE
- Indication: SOLUTION, ELIXIR — ORAL
- Status: approved
FDA — authorised 3 June 2021
- Application: ANDA212184
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 October 2022
- Application: ANDA216961
- Marketing authorisation holder: TEVA PHARMS INC
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 30 January 2023
- Application: ANDA214950
- Marketing authorisation holder: VELZEN PHARMA PVT
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 March 2023
- Application: ANDA216276
- Marketing authorisation holder: AMNEAL
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 April 2023
- Application: ANDA216300
- Marketing authorisation holder: BIONPHARMA
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 May 2023
- Application: ANDA214113
- Marketing authorisation holder: RHODES PHARMS
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 September 2023
- Application: ANDA217422
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 October 2023
- Application: ANDA214806
- Marketing authorisation holder: HARMAN FINOCHEM
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 May 2024
- Application: ANDA218063
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 5 September 2024
- Application: ANDA215312
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 January 2025
- Application: ANDA218401
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: THEOPHYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA085502
- Marketing authorisation holder: FOREST LABS
- Local brand name: ELIXICON
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA085205
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-PHYLLIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA085206
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-PHYLLIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA085665
- Marketing authorisation holder: ROERIG
- Local brand name: SUSTAIRE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA087910
- Marketing authorisation holder: SCHERING
- Local brand name: THEOVENT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA087095
- Marketing authorisation holder: CENT PHARMS
- Local brand name: THEOCLEAR-80
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA087010
- Marketing authorisation holder: SCHERING
- Local brand name: THEOVENT
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA087225
- Marketing authorisation holder: WARNER CHILCOTT
- Local brand name: LABID
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA088654
- Marketing authorisation holder: CENT PHARMS
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA084559
- Marketing authorisation holder: PANRAY
- Local brand name: THEOLIXIR
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA086001
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: THEOPHYLLINE
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA087917
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: AQUAPHYLLIN
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA088746
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: ACCURBRON
- Indication: SYRUP — ORAL
- Status: approved
FDA
- Application: ANDA085952
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA086506
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: THEOPHYL
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA
- Application: ANDA085203
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: SLO-PHYLLIN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA084739
- Marketing authorisation holder: ROXANE
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Application: ANDA088303
- Marketing authorisation holder: CENCI
- Local brand name: ELIXOMIN
- Indication: ELIXIR — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA085264
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: BRONKODYL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA089932
- Marketing authorisation holder: HOSPIRA
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA087155
- Marketing authorisation holder: FISONS
- Local brand name: SOMOPHYLLIN-T
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA089976
- Marketing authorisation holder: HOSPIRA
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA089977
- Marketing authorisation holder: HOSPIRA
- Local brand name: THEOPHYLLINE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA086569
- Marketing authorisation holder: SCHWARZ PHARMA
- Local brand name: THEOCLEAR L.A.-260
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA089223
- Marketing authorisation holder: ALPHARMA US PHARMS
- Local brand name: THEOPHYLLINE
- Indication: ELIXIR — ORAL
- Status: approved
Aminophylline group in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Aminophylline group approved in United States?
Yes. FDA authorised it on 26 July 1976; FDA authorised it on 26 January 1979; FDA authorised it on 8 February 1979.
Who is the marketing authorisation holder for Aminophylline group in United States?
LANNETT holds the US marketing authorisation.