Details for New Drug Application (NDA): 065355
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NDA 065355 describes SUPRAX, which is a drug marketed by Lupin Ltd, Lederle, and Lupin Pharms, and is included in eight NDAs. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the SUPRAX profile page.
The generic ingredient in SUPRAX is cefixime. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the cefixime profile page.
The generic ingredient in SUPRAX is cefixime. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the cefixime profile page.
Summary for 065355
| Tradename: | SUPRAX |
| Applicant: | Lupin Pharms |
| Ingredient: | cefixime |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065355
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUPRAX | cefixime | FOR SUSPENSION;ORAL | 065355 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-407 | 68180-407-03 | 50 mL in 1 BOTTLE (68180-407-03) |
| SUPRAX | cefixime | FOR SUSPENSION;ORAL | 065355 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-407 | 68180-407-04 | 75 mL in 1 BOTTLE (68180-407-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
| Approval Date: | Apr 10, 2007 | TE: | AB | RLD: | No | ||||
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