Details for New Drug Application (NDA): 213568
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NDA 213568 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-two NDAs. It is available from thirty-six 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-six 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-six suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 213568
| Tradename: | CEPHALEXIN |
| Applicant: | Aurobindo Pharma |
| Ingredient: | cephalexin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213568
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 213568 | ANDA | Aurobindo Pharma Limited | 59651-322 | 59651-322-01 | 100 mL in 1 BOTTLE (59651-322-01) |
| CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 213568 | ANDA | Aurobindo Pharma Limited | 59651-322 | 59651-322-02 | 200 mL in 1 BOTTLE (59651-322-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 125MG BASE/5ML | ||||
| Approval Date: | Jun 9, 2026 | 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: | Jun 9, 2026 | TE: | AB | RLD: | No | ||||
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