Orange Book product · Brand (NDA)
VICOPROFEN
HYDROCODONE BITARTRATE; IBUPROFEN
At a glance
Sep 23, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 23, 1997
29 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE; IBUPROFEN
Strength
7.5MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020716
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.
- 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
- 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.
