FDA — authorised 20 October 1975
- Application: ANDA083790
- Marketing authorisation holder: NUMARK
- Local brand name: MELFIAT
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 PHENDIMETRAZINE TARTRATE in United States
FDA authorised PHENDIMETRAZINE TARTRATE on 20 October 1975 · 58 US adverse-event reports
Marketing authorisations
FDA — authorised 22 July 1976
- Application: ANDA083682
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 September 1976
- Application: ANDA083655
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: ADPHEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 1976
- Application: ANDA085272
- Marketing authorisation holder: BAUSCH
- Local brand name: BONTRIL PDM
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 1977
- Application: ANDA083684
- Marketing authorisation holder: BARR
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 January 1977
- Application: ANDA083686
- Marketing authorisation holder: BARR
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 1977
- Application: ANDA083644
- Marketing authorisation holder: BARR
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 January 1977
- Application: ANDA083687
- Marketing authorisation holder: BARR
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 1977
- Application: ANDA085321
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CAM-METRAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 1977
- Application: ANDA085318
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CAM-METRAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 January 1977
- Application: ANDA085320
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CAM-METRAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1977
- Application: ANDA085512
- Marketing authorisation holder: ABC HOLDING
- Local brand name: PHENAZINE-35
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 May 1977
- Application: ANDA085511
- Marketing authorisation holder: ABC HOLDING
- Local brand name: CAM-METRAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 1977
- Application: ANDA085698
- Marketing authorisation holder: PVT FORM
- Local brand name: DI-METREX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 1977
- Application: ANDA085611
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 May 1977
- Application: ANDA085756
- Marketing authorisation holder: CAMALL
- Local brand name: CAM-METRAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 May 1977
- Application: ANDA085612
- Marketing authorisation holder: IVAX PHARMS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 June 1977
- Application: ANDA085525
- Marketing authorisation holder: KV PHARM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 1977
- Application: ANDA085761
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 1977
- Application: ANDA085588
- Marketing authorisation holder: ACERTIS PHARMS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 August 1977
- Application: ANDA085497
- Marketing authorisation holder: VIRTUS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 1977
- Application: ANDA084835
- Marketing authorisation holder: BARR
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 1977
- Application: ANDA084834
- Marketing authorisation holder: BARR
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 1977
- Application: ANDA084831
- Marketing authorisation holder: BARR
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 1977
- Application: ANDA085768
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 1977
- Application: ANDA085770
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 1977
- Application: ANDA085767
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 November 1977
- Application: ANDA085773
- Marketing authorisation holder: WATSON LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 December 1977
- Application: ANDA086013
- Marketing authorisation holder: TEVA
- Local brand name: STATOBEX
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 1978
- Application: ANDA086020
- Marketing authorisation holder: NEXGEN PHARMA INC
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 1978
- Application: ANDA085507
- Marketing authorisation holder: TEVA
- Local brand name: STATOBEX
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 April 1978
- Application: ANDA085034
- Marketing authorisation holder: SANDOZ
- Local brand name: ALPHAZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 June 1978
- Application: ANDA085695
- Marketing authorisation holder: VIRTUS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 June 1978
- Application: ANDA085694
- Marketing authorisation holder: SANDOZ
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 June 1978
- Application: ANDA085702
- Marketing authorisation holder: SANDOZ
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 July 1978
- Application: ANDA085633
- Marketing authorisation holder: SANDOZ
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 April 1979
- Application: NDA018074
- Marketing authorisation holder: ACERTIS PHARMS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 May 1981
- Application: ANDA084399
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1981
- Application: ANDA086553
- Marketing authorisation holder: SHIRE RICHWOOD
- Local brand name: X-TROZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1981
- Application: ANDA086554
- Marketing authorisation holder: SHIRE RICHWOOD
- Local brand name: X-TROZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1981
- Application: ANDA086552
- Marketing authorisation holder: SHIRE RICHWOOD
- Local brand name: X-TROZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1981
- Application: ANDA086551
- Marketing authorisation holder: SHIRE RICHWOOD
- Local brand name: X-TROZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 1981
- Application: ANDA086550
- Marketing authorisation holder: SHIRE RICHWOOD
- Local brand name: X-TROZINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 1981
- Application: ANDA086365
- Marketing authorisation holder: VIRTUS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 November 1981
- Application: ANDA087378
- Marketing authorisation holder: VIRTUS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 May 1982
- Application: ANDA085670
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 May 1982
- Application: ANDA086005
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 1982
- Application: ANDA085519
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 1982
- Application: ANDA086106
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 1982
- Application: ANDA086410
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 May 1982
- Application: ANDA086408
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 June 1982
- Application: ANDA085645
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 July 1982
- Application: ANDA086370
- Marketing authorisation holder: SANDOZ
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 August 1982
- Application: ANDA085634
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 August 1982
- Application: ANDA088020
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 August 1982
- Application: ANDA088028
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 August 1982
- Application: ANDA087371
- Marketing authorisation holder: SHIRE RICHWOOD
- Local brand name: X-TROZINE L.A.
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 September 1982
- Application: ANDA088063
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 21 September 1982
- Application: ANDA088021
- Marketing authorisation holder: VALEANT
- Local brand name: BONTRIL
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 September 1982
- Application: ANDA087394
- Marketing authorisation holder: SHIRE RICHWOOD
- Local brand name: X-TROZINE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 October 1982
- Application: ANDA087487
- Marketing authorisation holder: NUMARK
- Local brand name: MELFIAT-105
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 18 October 1982
- Application: ANDA088111
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 22 December 1982
- Application: ANDA088024
- Marketing authorisation holder: NUMARK
- Local brand name: SPRX-105
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 June 1983
- Application: ANDA085941
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 August 1983
- Application: ANDA086403
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 September 1983
- Application: ANDA086834
- Marketing authorisation holder: FERNDALE LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 October 1991
- Application: ANDA089452
- Marketing authorisation holder: CHARTWELL
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 January 2008
- Application: ANDA040762
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 August 2010
- Application: ANDA091042
- Marketing authorisation holder: KVK TECH
- Status: approved
FDA — authorised 27 December 2017
- Application: ANDA203600
- Marketing authorisation holder: MPP PHARMA
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083754
- Marketing authorisation holder: FOREST PHARMS
- Local brand name: METRA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085914
- Marketing authorisation holder: MFG CHEMISTS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084138
- Marketing authorisation holder: KV PHARM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084740
- Marketing authorisation holder: INWOOD LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085697
- Marketing authorisation holder: PVT FORM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA084741
- Marketing authorisation holder: INWOOD LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084398
- Marketing authorisation holder: USL PHARMA
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084742
- Marketing authorisation holder: INWOOD LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084743
- Marketing authorisation holder: INWOOD LABS
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA083805
- Marketing authorisation holder: USL PHARMA
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA087424
- Marketing authorisation holder: VITARINE
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087214
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: NDA012248
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PLEGINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084141
- Marketing authorisation holder: KV PHARM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085199
- Marketing authorisation holder: PVT FORM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA088062
- Marketing authorisation holder: GRAHAM DM
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA085095
- Marketing authorisation holder: TEVA
- Local brand name: STATOBEX-G
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA085897
- Marketing authorisation holder: SOLVAY
- Local brand name: SPRX-3
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA083993
- Marketing authorisation holder: SOLVAY
- Local brand name: PHENDIMETRAZINE TARTRATE
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 58
Most-reported reactions
- Drug Ineffective — 11 reports (18.97%)
- Pain — 7 reports (12.07%)
- Headache — 6 reports (10.34%)
- Weight Increased — 6 reports (10.34%)
- Back Pain — 5 reports (8.62%)
- Dyspnoea — 5 reports (8.62%)
- Off Label Use — 5 reports (8.62%)
- Wrong Technique In Product Usage Process — 5 reports (8.62%)
- Choroidal Effusion — 4 reports (6.9%)
- Fatigue — 4 reports (6.9%)
PHENDIMETRAZINE TARTRATE 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 PHENDIMETRAZINE TARTRATE approved in United States?
Yes. FDA authorised it on 20 October 1975; FDA authorised it on 22 July 1976; FDA authorised it on 29 September 1976.
Who is the marketing authorisation holder for PHENDIMETRAZINE TARTRATE in United States?
NUMARK holds the US marketing authorisation.