DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 071265
NDA 071265 describes PROFEN, which is a drug marketed by Contract Pharmacal and Alcon and is included in two NDAs. It is available from one supplier. Additional details are available on the PROFEN profile page.
The generic ingredient in PROFEN is suprofen. There are four drug master file entries for this compound. Additional details are available on the suprofen profile page.
The generic ingredient in PROFEN is suprofen. There are four drug master file entries for this compound. Additional details are available on the suprofen profile page.
Summary for 071265
| Tradename: | PROFEN |
| Applicant: | Contract Pharmacal |
| Ingredient: | ibuprofen |
| Patents: | 0 |
| Therapeutic Class: | Analgesics Anti-inflammatory Agents |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 071265
Suppliers and Packaging for NDA: 071265
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROFEN | ibuprofen | TABLET;ORAL | 071265 | ANDA | Contract Pharmacal Corp. | 10267-3846 | N | 10267-3846-2 |
| PROFEN | ibuprofen | TABLET;ORAL | 071265 | ANDA | Contract Pharmacal Corp. | 10267-3852 | N | 10267-3852-2 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Oct 15, 1986 | TE: | RLD: | No | |||||
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