Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND IBUPROFEN
HYDROCODONE BITARTRATE; IBUPROFEN
At a glance
Jun 02, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 02, 2016
10 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE; IBUPROFEN
Strength
7.5MG;200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 204575
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCODONE BITARTRATE; IBUPROFEN
- 1997VICOPROFENBrand (NDA)
NDA 020716 · ABBVIE
- 2013HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 091633 · SUN PHARM INDS INC
- 2010HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 077454 · ANI PHARMS
- 2006HYDROCODONEGeneric (ANDA)
ANDA 077723 · STRIDES PHARMA
- 2004HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 076642 · AMNEAL PHARMS NY
- 2003HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 076604 · ACTAVIS LABS FL INC
- 2003HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 076023 · TEVA
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.
