Orange Book product · Generic (ANDA)
BUTALBITAL AND ACETAMINOPHEN
ACETAMINOPHEN; BUTALBITAL
At a glance
Feb 01, 2024
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 01, 2024
2 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; BUTALBITAL
Strength
300MG;50MG
Dosage form
TABLET
Route
ORAL
TE code
AA
Application
ANDA 214305
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ACETAMINOPHEN; BUTALBITAL
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ANDA 090956 · LGM PHARMA
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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.
