DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 065473
NDA 065473 describes CEFDINIR, which is a drug marketed by Aurobindo Pharma, Lupin, Orchid Hlthcare, Sandoz, and Teva Pharms, and is included in ten NDAs. It is available from thirty-two 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. Thirty-two 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. Thirty-two 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 | 16714-392-01 |
| CEFDINIR | cefdinir | FOR SUSPENSION;ORAL | 065473 | ANDA | NorthStar Rx LLC | 16714-392 | N | 16714-392-02 |
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 | ||||
Complete Access Available with Subscription
