Details for New Drug Application (NDA): 077349
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The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen sodium profile page.
Summary for 077349
Tradename: | IBUPROFEN |
Applicant: | Perrigo R And D |
Ingredient: | ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 077349
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 077349
Suppliers and Packaging for NDA: 077349
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | TABLET;ORAL | 077349 | ANDA | L. Perrigo Company | 0113-0074 | 0113-0074-71 | 1 BOTTLE in 1 CARTON (0113-0074-71) / 50 TABLET, FILM COATED in 1 BOTTLE |
IBUPROFEN | ibuprofen | TABLET;ORAL | 077349 | ANDA | L. Perrigo Company | 0113-0074 | 0113-0074-78 | 1 BOTTLE in 1 CARTON (0113-0074-78) / 100 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Jun 21, 2005 | TE: | RLD: | No |
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