Details for New Drug Application (NDA): 074916
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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 074916
Tradename: | IBUPROFEN |
Applicant: | P And L |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074916
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074916
Suppliers and Packaging for NDA: 074916
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 074916 | ANDA | Pharmaceutical Associates, Inc. | 0121-0914 | 0121-0914-00 | 10 TRAY in 1 CASE (0121-0914-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0914-05) |
IBUPROFEN | ibuprofen | SUSPENSION;ORAL | 074916 | ANDA | Pharmaceutical Associates, Inc. | 0121-0917 | 0121-0917-00 | 10 TRAY in 1 CASE (0121-0917-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0917-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
Approval Date: | Apr 30, 1999 | TE: | RLD: | No |
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