Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN; HYDROCODONE BITARTRATE
At a glance
Sep 25, 2003
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 25, 2003
23 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength
325MG/15ML;7.5MG/15ML
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
ANDA 040482
Product number
001
Marketing status
DISCN
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 090468 · CYPRESS PHARM INC
- 2013HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 040838 · PHARM ASSOC
- 2012HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
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- 2011HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
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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.
