Details for New Drug Application (NDA): 079233
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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 079233
Tradename: | IBUPROFEN |
Applicant: | Amneal Pharms |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 079233
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 079233
Suppliers and Packaging for NDA: 079233
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | TABLET;ORAL | 079233 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-458 | 53746-458-02 | 250 TABLET in 1 BOTTLE (53746-458-02) |
IBUPROFEN | ibuprofen | TABLET;ORAL | 079233 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-458 | 53746-458-10 | 1000 TABLET in 1 BOTTLE (53746-458-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Mar 18, 2014 | TE: | RLD: | No |
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