DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 065473
The generic ingredient in CEFDINIR is cefdinir. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Summary for 065473
Tradename: | CEFDINIR |
Applicant: | Aurobindo Pharma |
Ingredient: | cefdinir |
Patents: | 0 |
Therapeutic Class: | Antibacterials |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065473
Ingredient-type | Cephalosporins |
Suppliers and Packaging for NDA: 065473
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065473 | ANDA | NorthStar Rx LLC | 16714-392 | N | 16714-392-02 |
CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065473 | ANDA | NorthStar Rx LLC | 16714-392 | N | 16714-392-01 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
Approval Date: | Dec 14, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
Approval Date: | Dec 14, 2007 | TE: | AB | RLD: | No |
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