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 |
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 | PLD Acquisitions LLC DBA Av?ma Pharma Solutions | 63548-0185 | 63548-0185-1 | 10 TABLET, COATED in 1 VIAL (63548-0185-1) |
IBUPROFEN | ibuprofen | TABLET;ORAL | 076460 | ANDA | PLD Acquisitions LLC DBA Av?ma Pharma Solutions | 63548-0185 | 63548-0185-2 | 1 BOTTLE in 1 BOX (63548-0185-2) / 100 TABLET, COATED in 1 BOTTLE |
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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