Orange Book product · Generic (ANDA)
ACETAMINOPHEN AND IBUPROFEN
ACETAMINOPHEN; IBUPROFEN
At a glance
Feb 28, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 28, 2023
3 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ACETAMINOPHEN; IBUPROFEN
Strength
250MG;125MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 214836
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
No
Reference standard (RS)
No
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.
