Orange Book product · Brand (NDA)
ZANTAC
RANITIDINE HYDROCHLORIDE
At a glance
Oct 19, 1984
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 19, 1984
42 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
RANITIDINE HYDROCHLORIDE
Strength
EQ 25MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019090
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this 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
- 1991ZANTAC IN PLASTIC CONTAINERBrand (NDA)
NDA 019593 · PAI HOLDINGS PHARM
- 1988ZANTACBrand (NDA)
NDA 019675 · GLAXO GRP LTD
- 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.
