Details for New Drug Application (NDA): 065412
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NDA 065412 describes CEFACLOR, which is a drug marketed by Ceph Intl, Chartwell Rx, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, Ranbaxy, Teva, Yung Shin Pharm, Facta Farma, Watson Labs Inc, and World Gen, and is included in twenty-nine NDAs. It is available from four suppliers. Additional details are available on the CEFACLOR profile page.
The generic ingredient in CEFACLOR is cefaclor. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefaclor profile page.
The generic ingredient in CEFACLOR is cefaclor. There are thirteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefaclor profile page.
Summary for 065412
| Tradename: | CEFACLOR |
| Applicant: | Yung Shin Pharm |
| Ingredient: | cefaclor |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065412
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFACLOR | cefaclor | FOR SUSPENSION;ORAL | 065412 | ANDA | Azorian Pharma, LLC | 81948-6250 | 81948-6250-1 | 150 mL in 1 BOTTLE (81948-6250-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 125MG BASE/5ML | ||||
| Approval Date: | Feb 17, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 187MG BASE/5ML | ||||
| Approval Date: | Feb 17, 2012 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
| Approval Date: | Feb 17, 2012 | TE: | RLD: | No | |||||
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