Orange Book product · Generic (ANDA)
BUTALBITAL AND ACETAMINOPHEN
ACETAMINOPHEN; BUTALBITAL
At a glance
Aug 23, 2011
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 23, 2011
15 yr ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL
Strength
300MG;50MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 090956
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
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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.
