Details for New Drug Application (NDA): 065058
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NDA 065058 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.
Suppliers and Packaging for NDA: 065058
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFACLOR | cefaclor | TABLET, EXTENDED RELEASE;ORAL | 065058 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1087 | 0093-1087-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-1087-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 375MG BASE | ||||
| Approval Date: | Sep 4, 2002 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Sep 4, 2002 | TE: | RLD: | No | |||||
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