Details for New Drug Application (NDA): 076460
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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 076460
Tradename: | IBUPROFEN |
Applicant: | Avema Pharma |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076460
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076460
Suppliers and Packaging for NDA: 076460
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | TABLET;ORAL | 076460 | ANDA | Family Dollar (FAMILY WELLNESS) | 55319-186 | 55319-186-01 | 1 BOTTLE, PLASTIC in 1 BOX (55319-186-01) / 100 TABLET in 1 BOTTLE, PLASTIC |
IBUPROFEN | ibuprofen | TABLET;ORAL | 076460 | ANDA | Family Dollar (FAMILY WELLNESS) | 55319-186 | 55319-186-25 | 1 BOTTLE, PLASTIC in 1 BOX (55319-186-25) / 250 TABLET in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Nov 26, 2003 | TE: | RLD: | No |
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