FDA — authorised 16 August 1977
- Application: NDA017939
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TAGAMET
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Tagamet in United States
FDA authorised Tagamet on 16 August 1977
Marketing authorisations
FDA — authorised 16 August 1977
- Status: approved
FDA — authorised 16 August 1977
- Application: NDA017924
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TAGAMET
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 August 1977
- Application: NDA017920
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: TAGAMET
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 1994
- Application: ANDA074329
- Marketing authorisation holder: CHARTWELL MOLECULES
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 May 1994
- Application: ANDA074246
- Marketing authorisation holder: MYLAN
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1994
- Application: ANDA074371
- Marketing authorisation holder: CYCLE
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1994
- Application: ANDA074361
- Marketing authorisation holder: CYCLE
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 1995
- Application: ANDA074100
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 February 1995
- Application: ANDA074365
- Marketing authorisation holder: TEVA
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 1995
- Application: ANDA074401
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 1995
- Application: ANDA074402
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1995
- Application: NDA020238
- Marketing authorisation holder: MEDTECH PRODUCTS
- Local brand name: TAGAMET HB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 1995
- Application: ANDA074340
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 June 1995
- Application: ANDA074339
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 June 1995
- Application: ANDA074250
- Marketing authorisation holder: SANDOZ
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 1995
- Application: ANDA074424
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 1996
- Application: ANDA074506
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 January 1996
- Application: ANDA074151
- Marketing authorisation holder: TEVA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 31 January 1996
- Application: ANDA074463
- Marketing authorisation holder: TEVA
- Indication: Labeling
- Status: approved
FDA — authorised 28 February 1996
- Application: ANDA074316
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 1996
- Application: ANDA074349
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1997
- Application: ANDA074566
- Marketing authorisation holder: PLIVA
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1997
- Application: ANDA074568
- Marketing authorisation holder: PLIVA
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1998
- Application: ANDA074961
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1998
- Application: ANDA074972
- Marketing authorisation holder: PERRIGO
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1998
- Application: ANDA074948
- Marketing authorisation holder: APOTEX
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 1998
- Application: ANDA074963
- Marketing authorisation holder: CONTRACT PHARMACAL
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 October 1998
- Application: ANDA075285
- Marketing authorisation holder: L PERRIGO CO
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 1998
- Application: ANDA074890
- Marketing authorisation holder: HIKMA
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 June 1999
- Application: ANDA075345
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 November 2024
- Application: ANDA218220
- Marketing authorisation holder: BIONPHARMA
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 2024
- Application: ANDA218997
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: CIMETIDINE
- Indication: TABLET — ORAL
- Status: approved
Tagamet in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Tagamet approved in United States?
Yes. FDA authorised it on 16 August 1977; FDA authorised it on 16 August 1977; FDA authorised it on 16 August 1977.
Who is the marketing authorisation holder for Tagamet in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.