Details for New Drug Application (NDA): 214836
✉ Email this page to a colleague
The generic ingredient in ACETAMINOPHEN AND IBUPROFEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.
Summary for 214836
Tradename: | ACETAMINOPHEN AND IBUPROFEN |
Applicant: | L Perrigo Co |
Ingredient: | acetaminophen; ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 214836
Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 214836
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 214836 | ANDA | L. Perrigo Company | 0113-5299 | 0113-5299-16 | 1 BOTTLE in 1 CARTON (0113-5299-16) / 144 TABLET, FILM COATED in 1 BOTTLE |
ACETAMINOPHEN AND IBUPROFEN | acetaminophen; ibuprofen | TABLET;ORAL | 214836 | ANDA | L. Perrigo Company | 0113-5299 | 0113-5299-23 | 1 BOTTLE in 1 CARTON (0113-5299-23) / 72 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 250MG;125MG | ||||
Approval Date: | Feb 28, 2023 | TE: | RLD: | No |
Complete Access Available with Subscription