Orange Book product · Generic (ANDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN; HYDROCODONE BITARTRATE
At a glance
Oct 25, 2002
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 25, 2002
24 yr ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength
750MG;7.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 040469
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 209036 · ABHAI LLC
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ANDA 209037 · ABHAI LLC
- 2016HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
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- 2016ZYFRELGeneric (ANDA)
ANDA 090468 · CYPRESS PHARM INC
- 2013HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 040838 · PHARM ASSOC
- 2012HYDROCODONE BITARTRATE AND ACETAMINOPHENGeneric (ANDA)
ANDA 200343 · GENUS
- 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.
