Details for New Drug Application (NDA): 065259
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The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Suppliers and Packaging for NDA: 065259
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065259 | ANDA | A-S Medication Solutions | 50090-3723 | 50090-3723-0 | 100 mL in 1 BOTTLE (50090-3723-0) |
CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065259 | ANDA | A-S Medication Solutions | 50090-6171 | 50090-6171-0 | 60 mL in 1 BOTTLE (50090-6171-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
Approval Date: | May 31, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
Approval Date: | May 7, 2007 | TE: | AB | RLD: | No |
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