Details for New Drug Application (NDA): 075217
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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 075217
Tradename: | IBUPROFEN |
Applicant: | L Perrigo Co |
Ingredient: | ibuprofen |
Patents: | 0 |
Pharmacology for NDA: 075217
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075217
Suppliers and Packaging for NDA: 075217
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IBUPROFEN | ibuprofen | SUSPENSION/DROPS;ORAL | 075217 | ANDA | L. Perrigo Company | 0113-0057 | 0113-0057-05 | 1 BOTTLE in 1 CARTON (0113-0057-05) / 15 mL in 1 BOTTLE |
IBUPROFEN | ibuprofen | SUSPENSION/DROPS;ORAL | 075217 | ANDA | Walgreen Company | 0363-8139 | 0363-8139-10 | 1 BOTTLE in 1 CARTON (0363-8139-10) / 30 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION/DROPS;ORAL | Strength | 40MG/ML | ||||
Approval Date: | Dec 16, 1998 | TE: | RLD: | No |
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