Details for New Drug Application (NDA): 203195
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NDA 203195 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.
Medical Subject Heading (MeSH) Categories for 203195
Suppliers and Packaging for NDA: 203195
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUPRAX | cefixime | CAPSULE;ORAL | 203195 | NDA AUTHORIZED GENERIC | Lupin Pharmaceuticals, Inc. | 68180-423 | 68180-423-08 | 50 CAPSULE in 1 BOTTLE (68180-423-08) |
| SUPRAX | cefixime | CAPSULE;ORAL | 203195 | NDA AUTHORIZED GENERIC | Lupin Pharmaceuticals, Inc. | 68180-423 | 68180-423-11 | 1 BLISTER PACK in 1 CARTON (68180-423-11) / 10 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 1, 2012 | TE: | AB | RLD: | Yes | ||||
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