Details for New Drug Application (NDA): 090836
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NDA 090836 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-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 090836
| Tradename: | CEPHALEXIN |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | cephalexin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 090836
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | cephalexin | CAPSULE;ORAL | 090836 | ANDA | Major Pharmaceuticals | 0904-7336 | 0904-7336-61 | 100 BLISTER PACK in 1 CARTON (0904-7336-61) / 1 CAPSULE in 1 BLISTER PACK |
| CEPHALEXIN | cephalexin | CAPSULE;ORAL | 090836 | ANDA | Major Pharmaceuticals | 0904-7337 | 0904-7337-06 | 50 BLISTER PACK in 1 CARTON (0904-7337-06) / 1 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Dec 20, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Dec 20, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 333MG BASE | ||||
| Approval Date: | Mar 29, 2013 | TE: | RLD: | No | |||||
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