Orange Book product · Brand (NDA)
TAGAMET
CIMETIDINE
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
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 017920
Product number
002
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.
- 1999TAGAMET HB 200Brand (NDA)
NDA 020951 · GLAXOSMITHKLINE
- 1995TAGAMET HBBrand (NDA)
NDA 020238 · MEDTECH PRODUCTS
- 2024CIMETIDINEGeneric (ANDA)
ANDA 218997 · AUROBINDO PHARMA LTD
- 2024CIMETIDINEGeneric (ANDA)
ANDA 218220 · BIONPHARMA
- 1999CIMETIDINEGeneric (ANDA)
ANDA 075425 · WATSON LABS TEVA
- 1999CIMETIDINEGeneric (ANDA)
ANDA 075345 · IVAX SUB TEVA PHARMS
- 1998CIMETIDINEGeneric (ANDA)
ANDA 074890 · HIKMA
- 1998CIMETIDINEGeneric (ANDA)
ANDA 075285 · L PERRIGO CO
- 1998CIMETIDINEGeneric (ANDA)
ANDA 074948 · APOTEX
- 1998CIMETIDINEGeneric (ANDA)
ANDA 074961 · CONTRACT PHARMACAL
- 1998CIMETIDINEGeneric (ANDA)
ANDA 074963 · CONTRACT PHARMACAL
- 1998CIMETIDINEGeneric (ANDA)
ANDA 074972 · PERRIGO
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.
