Details for New Drug Application (NDA): 204835
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NDA 204835 describes CEFIXIME, which is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Belcher, and Chartwell Rx, 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 204835
| Tradename: | CEFIXIME |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | cefixime |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204835
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFIXIME | cefixime | FOR SUSPENSION;ORAL | 204835 | ANDA | Aurobindo Pharma Limited | 65862-751 | 65862-751-01 | 100 mL in 1 BOTTLE (65862-751-01) |
| CEFIXIME | cefixime | FOR SUSPENSION;ORAL | 204835 | ANDA | Aurobindo Pharma Limited | 65862-751 | 65862-751-50 | 50 mL in 1 BOTTLE (65862-751-50) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 100MG/5ML | ||||
| Approval Date: | Apr 14, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 200MG/5ML | ||||
| Approval Date: | Apr 14, 2015 | TE: | AB | RLD: | No | ||||
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