Orange Book product · Brand (NDA)
TAGAMET
CIMETIDINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
CIMETIDINE HYDROCHLORIDE
Strength
EQ 300MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 017924
Product number
001
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.
- 1985TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERBrand (NDA)
NDA 019434 · GLAXOSMITHKLINE
- —TAGAMETBrand (NDA)
NDA 017939 · GLAXOSMITHKLINE
- 2000CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075560 · PHARM ASSOC
- 1998CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074859 · ANI PHARMS
- 1998CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 075110 · ANI PHARMS
- 1997CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074252 · TEVA PARENTERAL
- 1997CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074664 · PAI HOLDINGS PHARM
- 1997CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074757 · PHARMOBEDIENT CNSLTG
- 1997CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074541 · CYCLE
- 1997CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074296 · HOSPIRA
- 1997CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074412 · HOSPIRA
- 1997CIMETIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074553 · PHARM ASSOC
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.
