Orange Book product · Brand (NDA)
TAGAMET HB
CIMETIDINE
At a glance
Jun 19, 1995
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 19, 1995
31 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
CIMETIDINE
Strength
100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020238
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.
- 1999TAGAMET HB 200Brand (NDA)
NDA 020951 · GLAXOSMITHKLINE
- —TAGAMETBrand (NDA)
NDA 017920 · GLAXOSMITHKLINE
- 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.
