Details for New Drug Application (NDA): 062703
✉ Email this page to a colleague
NDA 062703 describes CEPHALEXIN, which is a drug marketed by Ajenat Pharms, Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Chartwell Rx, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Hikma Pharms, Vitarine, Yung Shin Pharm, and Aurobindo Pharma Ltd, and is included in fifty-one NDAs. It is available from thirty-five suppliers. Additional details are available on the CEPHALEXIN profile page.
The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 062703
| Tradename: | CEPHALEXIN |
| Applicant: | Teva |
| Ingredient: | cephalexin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 062703
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 062703 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4175 | 0093-4175-73 | 100 mL in 1 BOTTLE (0093-4175-73) |
| CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 062703 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-4175 | 0093-4175-74 | 200 mL in 1 BOTTLE (0093-4175-74) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 125MG BASE/5ML | ||||
| Approval Date: | Feb 13, 1987 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
| Approval Date: | Feb 13, 1987 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
