Orange Book product · Brand (NDA)
ZANTAC IN PLASTIC CONTAINER
RANITIDINE HYDROCHLORIDE
At a glance
Sep 27, 1991
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 1991
35 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
RANITIDINE HYDROCHLORIDE
Strength
EQ 1MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019593
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1998ZANTAC 75Brand (NDA)
NDA 020745 · CHATTEM SANOFI
- 1994ZANTAC 150Brand (NDA)
NDA 020251 · GLAXO GRP LTD
- 1994ZANTAC 150Brand (NDA)
NDA 020095 · GLAXOSMITHKLINE
- 1988ZANTACBrand (NDA)
NDA 019675 · GLAXO GRP LTD
- 1984ZANTACBrand (NDA)
NDA 019090 · PAI HOLDINGS PHARM
- 2019RANITIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211893 · APPCO
- 2018RANITIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210681 · NOVITIUM PHARMA
- 2018RANITIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209859 · AJANTA PHARMA LTD
- 2018RANITIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 211058 · AUROBINDO PHARMA
- 2017RANITIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207579 · AUROBINDO PHARMA
- 2017RANITIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207578 · AUROBINDO PHARMA
- 2016RANITIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 079076 · MYLAN LABS LTD
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
