FDA — authorised 9 June 1983
- Application: NDA018703
- Marketing authorisation holder: GLAXO GRP LTD
- Local brand name: ZANTAC 150
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 RANITIDINE HYDROCHLORIDE in United States
FDA authorised RANITIDINE HYDROCHLORIDE on 9 June 1983
Marketing authorisations
FDA — authorised 17 December 1986
- Application: NDA019593
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: ZANTAC IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 March 1994
- Application: NDA020095
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: ZANTAC 150
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 August 1997
- Application: ANDA074023
- Marketing authorisation holder: MYLAN
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 August 1997
- Application: ANDA074662
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 September 1997
- Application: ANDA074680
- Marketing authorisation holder: APOTEX
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 October 1997
- Application: ANDA074864
- Marketing authorisation holder: WATSON LABS
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 1997
- Application: ANDA074655
- Marketing authorisation holder: SANDOZ
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 January 1998
- Application: ANDA075000
- Marketing authorisation holder: RANBAXY
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 February 1998
- Application: NDA020745
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: ZANTAC 75
- Indication: TABLET, EFFERVESCENT — ORAL
- Status: approved
FDA — authorised 30 July 1998
- Application: ANDA074552
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 1998
- Application: ANDA075165
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 December 1998
- Application: ANDA075208
- Marketing authorisation holder: WOCKHARDT LTD
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 January 1999
- Application: ANDA075180
- Marketing authorisation holder: PH HEALTH
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2000
- Application: ANDA075254
- Marketing authorisation holder: RANBAXY
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2000
- Application: ANDA075296
- Marketing authorisation holder: ANI PHARMS
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2000
- Application: ANDA075212
- Marketing authorisation holder: ANI PHARMS
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 January 2000
- Application: ANDA075497
- Marketing authorisation holder: RISING
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 March 2000
- Application: ANDA075294
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 May 2000
- Application: ANDA075167
- Marketing authorisation holder: APOTEX
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2000
- Application: ANDA075564
- Marketing authorisation holder: RISING
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 November 2000
- Application: ANDA075742
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 August 2002
- Application: ANDA076195
- Marketing authorisation holder: PERRIGO
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2002
- Application: ANDA075519
- Marketing authorisation holder: SANDOZ
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 October 2003
- Application: ANDA075557
- Marketing authorisation holder: TEVA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 August 2004
- Application: NDA021698
- Marketing authorisation holder: CHATTEM SANOFI
- Local brand name: ZANTAC 150
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 November 2004
- Application: ANDA074764
- Marketing authorisation holder: BEDFORD
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 December 2005
- Application: ANDA077426
- Marketing authorisation holder: ANI PHARMS
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 February 2006
- Application: ANDA077458
- Marketing authorisation holder: HIKMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 February 2006
- Application: ANDA076760
- Marketing authorisation holder: WOCKHARDT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2006
- Application: ANDA077824
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 February 2007
- Application: ANDA076124
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 21 September 2007
- Application: ANDA077405
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 November 2007
- Application: ANDA078653
- Marketing authorisation holder: WOCKHARDT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 December 2007
- Application: ANDA078448
- Marketing authorisation holder: RANBAXY
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 July 2008
- Application: ANDA078884
- Marketing authorisation holder: WOCKHARDT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 September 2008
- Application: ANDA078312
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 19 November 2008
- Application: ANDA078542
- Marketing authorisation holder: GLENMARK PHARMS
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 February 2009
- Application: ANDA079212
- Marketing authorisation holder: WOCKHARDT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 May 2009
- Application: ANDA090102
- Marketing authorisation holder: TORRENT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 26 May 2009
- Application: ANDA079211
- Marketing authorisation holder: WOCKHARDT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 27 August 2009
- Application: ANDA078684
- Marketing authorisation holder: NOSTRUM LABS INC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 11 December 2009
- Application: ANDA078701
- Marketing authorisation holder: WOCKHARDT
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 July 2010
- Application: ANDA078890
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 July 2010
- Application: ANDA090623
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 9 December 2010
- Application: ANDA091288
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 11 May 2011
- Application: ANDA091429
- Marketing authorisation holder: PERRIGO R AND D
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2011
- Application: ANDA077476
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 20 September 2011
- Application: ANDA091091
- Marketing authorisation holder: NOSTRUM LABS INC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 29 February 2012
- Application: ANDA201745
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2012
- Application: ANDA200172
- Marketing authorisation holder: APOTEX INC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 2013
- Application: ANDA091534
- Marketing authorisation holder: ZYDUS PHARMS USA INC
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2016
- Application: ANDA205512
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 2017
- Application: ANDA207578
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 November 2017
- Application: ANDA207579
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 November 2017
- Application: ANDA203694
- Marketing authorisation holder: MPP PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 February 2018
- Application: ANDA209161
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 March 2018
- Application: ANDA209160
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA211058
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 August 2018
- Application: ANDA210010
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2018
- Application: ANDA209859
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 November 2018
- Application: ANDA210681
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 April 2019
- Application: ANDA211893
- Marketing authorisation holder: APPCO
- Local brand name: RANITIDINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
RANITIDINE HYDROCHLORIDE 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 RANITIDINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 9 June 1983; FDA authorised it on 17 December 1986; FDA authorised it on 8 March 1994.
Who is the marketing authorisation holder for RANITIDINE HYDROCHLORIDE in United States?
GLAXO GRP LTD holds the US marketing authorisation.