Orange Book product · Generic (ANDA)
IBUPROFEN AND FAMOTIDINE
FAMOTIDINE; IBUPROFEN
At a glance
Mar 22, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 22, 2024
2 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
FAMOTIDINE; IBUPROFEN
Strength
26.6MG;800MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 203658
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FAMOTIDINE; IBUPROFEN
- 2011DUEXISBrand (NDA)
NDA 022519 · HORIZON
- 2025IBUPROFEN AND FAMOTIDINEGeneric (ANDA)
ANDA 219538 · AUROBINDO PHARMA LTD
- 2025IBUPROFEN AND FAMOTIDINEGeneric (ANDA)
ANDA 218684 · ZYDUS LIFESCIENCES
- 2024IBUPROFEN AND FAMOTIDINEGeneric (ANDA)
ANDA 215925 · TORRENT
- 2023IBUPROFEN AND FAMOTIDINEGeneric (ANDA)
ANDA 216814 · ASCENT PHARMS INC
- 2021IBUPROFEN AND FAMOTIDINEGeneric (ANDA)
ANDA 211278 · TEVA PHARMS USA
- 2021IBUPROFEN AND FAMOTIDINEGeneric (ANDA)
ANDA 211890 · ALKEM 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.
