Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN; HYDROCODONE BITARTRATE
At a glance
Mar 15, 2016
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 15, 2016
10 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength
300MG;5MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 202214
Product number
004
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; HYDROCODONE BITARTRATE
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ANDA 209037 · ABHAI LLC
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ANDA 040838 · PHARM ASSOC
- 2012HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 200343 · GENUS
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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.
