Details for New Drug Application (NDA): 065330
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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.
Summary for 065330
Tradename: | CEFDINIR |
Applicant: | Sandoz |
Ingredient: | cefdinir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065330
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFDINIR | cefdinir | CAPSULE;ORAL | 065330 | ANDA | Sandoz Inc | 0781-2176 | 0781-2176-01 | 100 CAPSULE in 1 BOTTLE (0781-2176-01) |
CEFDINIR | cefdinir | CAPSULE;ORAL | 065330 | ANDA | Sandoz Inc | 0781-2176 | 0781-2176-60 | 60 CAPSULE in 1 BOTTLE (0781-2176-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Apr 6, 2007 | TE: | AB | RLD: | No |
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