Details for New Drug Application (NDA): 210574
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NDA 210574 describes CEFIXIME, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Belcher, and Sandoz, and is included in six NDAs. It is available from seven suppliers. Additional details are available on the CEFIXIME profile page.
The generic ingredient in CEFIXIME is cefixime. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefixime profile page.
The generic ingredient in CEFIXIME is cefixime. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the cefixime profile page.
Summary for 210574
| Tradename: | CEFIXIME |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | cefixime |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210574
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFIXIME | cefixime | CAPSULE;ORAL | 210574 | ANDA | Ascend Laboratories, LLC | 67877-584 | 67877-584-01 | 100 CAPSULE in 1 BOTTLE (67877-584-01) |
| CEFIXIME | cefixime | CAPSULE;ORAL | 210574 | ANDA | Ascend Laboratories, LLC | 67877-584 | 67877-584-05 | 500 CAPSULE in 1 BOTTLE (67877-584-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 400MG | ||||
| Approval Date: | Oct 9, 2018 | TE: | AB | RLD: | No | ||||
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