Details for New Drug Application (NDA): 065253
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NDA 065253 describes CEPHALEXIN, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Belcher Pharms, 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-eight 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 065253
| Tradename: | CEPHALEXIN |
| Applicant: | Aurobindo Pharma |
| Ingredient: | cephalexin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065253
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | cephalexin | CAPSULE;ORAL | 065253 | ANDA | Medsource Pharmaceuticals | 45865-428 | 45865-428-28 | 28 CAPSULE in 1 BOTTLE (45865-428-28) |
| CEPHALEXIN | cephalexin | CAPSULE;ORAL | 065253 | ANDA | Medsource Pharmaceuticals | 45865-428 | 45865-428-30 | 30 CAPSULE in 1 BOTTLE (45865-428-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Nov 16, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Nov 16, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 750MG BASE | ||||
| Approval Date: | Dec 6, 2023 | TE: | AB | RLD: | No | ||||
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