Details for New Drug Application (NDA): 210534
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NDA 210534 describes CEFDINIR, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Aurobindo Pharma, Lupin, Sandoz, and Teva Pharms, and is included in twelve NDAs. It is available from twenty-eight suppliers. Additional details are available on the CEFDINIR profile page.
The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Summary for 210534
| Tradename: | CEFDINIR |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | cefdinir |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210534
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 210534 | ANDA | A-S Medication Solutions | 50090-5811 | 50090-5811-0 | 60 mL in 1 BOTTLE (50090-5811-0) |
| CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 210534 | ANDA | Ascend Laboratories, LLC | 67877-547 | 67877-547-88 | 100 mL in 1 BOTTLE (67877-547-88) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
| Approval Date: | Feb 19, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Feb 19, 2021 | TE: | AB | RLD: | No | ||||
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