Details for New Drug Application (NDA): 203599
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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 203599
Tradename: | IBUPROFEN |
Applicant: | Sofgen Pharms |
Ingredient: | ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 203599
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 203599
Suppliers and Packaging for NDA: 203599
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | CAPSULE;ORAL | 203599 | ANDA | L. Perrigo Company | 0113-0298 | 0113-0298-06 | 1 BOTTLE in 1 CARTON (0113-0298-06) / 160 CAPSULE, LIQUID FILLED in 1 BOTTLE |
IBUPROFEN | ibuprofen | CAPSULE;ORAL | 203599 | ANDA | L. Perrigo Company | 0113-0298 | 0113-0298-27 | 1 BOTTLE in 1 CARTON (0113-0298-27) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG FREE ACID AND POTASSIUM SALT | ||||
Approval Date: | Sep 7, 2016 | TE: | RLD: | No |
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