Details for New Drug Application (NDA): 202312
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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 202312
Tradename: | IBUPROFEN |
Applicant: | Granules |
Ingredient: | ibuprofen |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202312
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 202312
Suppliers and Packaging for NDA: 202312
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | TABLET;ORAL | 202312 | ANDA | Walgreens | 0363-9593 | 0363-9593-21 | 225 TABLET in 1 BOTTLE (0363-9593-21) |
IBUPROFEN | ibuprofen | TABLET;ORAL | 202312 | ANDA | BETTER LIVING BRANDS LLC. | 21130-358 | 21130-358-05 | 50 TABLET, COATED in 1 BOTTLE (21130-358-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Oct 7, 2016 | TE: | RLD: | No |
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