FDA — authorised 4 November 1986
- Application: NDA019510
- Marketing authorisation holder: MERCK
- Local brand name: PEPCID PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 H2 Receptor Antagonist in United States
FDA authorised H2 Receptor Antagonist on 4 November 1986
Marketing authorisations
FDA — authorised 28 May 1998
- Application: NDA020752
- Marketing authorisation holder: MERCK
- Local brand name: PEPCID RPD
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075651
- Marketing authorisation holder: SAGENT
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075805
- Marketing authorisation holder: CARLSBAD
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075669
- Marketing authorisation holder: HOSPIRA
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075486
- Marketing authorisation holder: HIKMA
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075488
- Marketing authorisation holder: HIKMA
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075786
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075684
- Marketing authorisation holder: SAGENT
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075622
- Marketing authorisation holder: SAGENT
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075813
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075311
- Marketing authorisation holder: TEVA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075302
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075793
- Marketing authorisation holder: SANDOZ
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075062
- Marketing authorisation holder: WATSON LABS
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 April 2001
- Application: ANDA075511
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2001
- Application: ANDA075825
- Marketing authorisation holder: SAGENT
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2001
- Application: ANDA075457
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 May 2001
- Application: ANDA075591
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 May 2001
- Application: ANDA075607
- Marketing authorisation holder: SANDOZ
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2001
- Application: ANDA075312
- Marketing authorisation holder: TEVA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 July 2001
- Application: ANDA075611
- Marketing authorisation holder: APOTEX
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 July 2001
- Application: ANDA075512
- Marketing authorisation holder: P AND L
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 September 2001
- Application: ANDA075650
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2001
- Application: ANDA075905
- Marketing authorisation holder: HOSPIRA
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 November 2001
- Application: ANDA075870
- Marketing authorisation holder: HOSPIRA
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 December 2001
- Application: ANDA075639
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 December 2001
- Application: ANDA075674
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 March 2002
- Application: ANDA075610
- Marketing authorisation holder: APOTEX
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 2002
- Application: ANDA075789
- Marketing authorisation holder: HIKMA
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 April 2002
- Application: ANDA075799
- Marketing authorisation holder: HIKMA
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 August 2002
- Application: ANDA075942
- Marketing authorisation holder: APOTEX INC
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 October 2002
- Application: ANDA076101
- Marketing authorisation holder: SANDOZ
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 November 2002
- Application: ANDA076322
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 November 2002
- Application: ANDA076324
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 September 2004
- Application: NDA021712
- Marketing authorisation holder: UCB INC
- Local brand name: FLUXID
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 7 March 2005
- Application: ANDA077146
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 March 2005
- Application: ANDA075400
- Marketing authorisation holder: PERRIGO
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 July 2005
- Application: ANDA077352
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2006
- Application: ANDA077351
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 September 2006
- Application: ANDA077367
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 February 2008
- Application: ANDA077355
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 25 June 2008
- Application: ANDA078642
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: FAMOTIDINE PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 June 2008
- Application: ANDA078641
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 May 2009
- Application: ANDA078916
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 2009
- Application: ANDA090283
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 2010
- Application: ANDA091020
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 June 2010
- Application: ANDA090440
- Marketing authorisation holder: LUPIN LTD
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 4 August 2010
- Application: ANDA090837
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 2012
- Application: ANDA201695
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 May 2014
- Application: ANDA201995
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 December 2015
- Application: ANDA206530
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 April 2016
- Application: ANDA206531
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 2016
- Application: ANDA204782
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
FDA — authorised 3 August 2021
- Application: ANDA211890
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: IBUPROFEN AND FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 October 2021
- Application: ANDA215689
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 2021
- Application: ANDA216030
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 November 2021
- Application: ANDA215767
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 November 2021
- Application: ANDA215766
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 January 2022
- Application: ANDA215630
- Marketing authorisation holder: VKT PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 January 2022
- Application: ANDA215822
- Marketing authorisation holder: VKT PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 June 2022
- Application: ANDA216441
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 August 2022
- Application: ANDA216427
- Marketing authorisation holder: AMNEAL
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 November 2022
- Application: ANDA215828
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 March 2023
- Application: ANDA217543
- Marketing authorisation holder: MARKSANS PHARMA
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 April 2023
- Application: ANDA217375
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2023
- Application: ANDA217137
- Marketing authorisation holder: CARNEGIE
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 17 August 2023
- Application: ANDA217330
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 September 2023
- Application: ANDA217842
- Marketing authorisation holder: MICRO LABS
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 September 2023
- Application: ANDA217529
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 December 2023
- Application: ANDA218181
- Marketing authorisation holder: RISING
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 January 2024
- Application: ANDA217605
- Marketing authorisation holder: UNICHEM
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 March 2024
- Application: ANDA218461
- Marketing authorisation holder: GRAVITI PHARMS
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 March 2024
- Application: ANDA203658
- Marketing authorisation holder: PH HEALTH
- Local brand name: IBUPROFEN AND FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 May 2024
- Application: ANDA218003
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 August 2024
- Application: ANDA217400
- Marketing authorisation holder: MSN
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2024
- Application: ANDA218344
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 20 February 2025
- Application: ANDA218684
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: IBUPROFEN AND FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 2025
- Application: ANDA218631
- Marketing authorisation holder: REGCON HOLDINGS
- Local brand name: FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 2025
- Application: ANDA217982
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 June 2025
- Application: ANDA219538
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: IBUPROFEN AND FAMOTIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 July 2025
- Application: ANDA219091
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 July 2025
- Application: NDA219935
- Marketing authorisation holder: SAGENT
- Local brand name: FAMOTIDINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 9 March 2026
- Application: ANDA219603
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: FAMOTIDINE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 May 2026
- Application: ANDA217432
- Marketing authorisation holder: LUPIN
- Local brand name: FAMOTIDINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA075194
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: FAMOTIDINE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA075193
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: FAMOTIDINE
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA075192
- Marketing authorisation holder: MARSAM PHARMS LLC
- Local brand name: FAMOTIDINE
- Indication: Injectable — Injection
- Status: approved
Other Gastroenterology approved in United States
Frequently asked questions
Is H2 Receptor Antagonist approved in United States?
Yes. FDA authorised it on 4 November 1986; FDA authorised it on 28 May 1998; FDA authorised it on 16 April 2001.
Who is the marketing authorisation holder for H2 Receptor Antagonist in United States?
MERCK holds the US marketing authorisation.