Orange Book product · Generic (ANDA)
FAMOTIDINE
FAMOTIDINE
At a glance
Apr 16, 2001
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 16, 2001
25 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
FAMOTIDINE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 075684
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FAMOTIDINE
- 2025FAMOTIDINEBrand (NDA)
NDA 219935 · SAGENT
- 2004FLUXIDBrand (NDA)
NDA 021712 · UCB INC
- 1998PEPCID ACBrand (NDA)
NDA 020801 · KENVUE BRANDS
- 1994PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINERBrand (NDA)
NDA 020249 · MERCK SHARP DOHME
- 1987PEPCIDBrand (NDA)
NDA 019527 · SALIX PHARMS
- 1986PEPCIDBrand (NDA)
NDA 019510 · MERCK
- 2026FAMOTIDINEGeneric (ANDA)
ANDA 217432 · LUPIN
- 2026FAMOTIDINEGeneric (ANDA)
ANDA 219603 · CONTRACT PHARMACAL
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 219863 · MSN
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 219091 · AUROBINDO PHARMA LTD
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 219153 · BIONPHARMA
- 2025FAMOTIDINEGeneric (ANDA)
ANDA 217982 · LANNETT CO INC
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.
