Orange Book product · Generic (ANDA)
HYDROCODONE
HYDROCODONE BITARTRATE; IBUPROFEN
At a glance
Nov 06, 2006
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 06, 2006
19 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE; IBUPROFEN
Strength
5MG;200MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 077723
Product number
003
Marketing status
DISCN
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
- 2016HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 204575 · AUROLIFE PHARMA LLC
- 2013HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 091633 · SUN PHARM INDS INC
- 2010HYDROCODONE BITARTRATE AND IBUPROFENGeneric (ANDA)
ANDA 077454 · ANI PHARMS
- 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.
