Details for New Drug Application (NDA): 065336
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NDA 065336 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 065336
| Tradename: | CEPHALEXIN |
| Applicant: | Yung Shin Pharm |
| Ingredient: | cephalexin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065336
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 065336 | ANDA | Chartwell RX, LLC | 62135-480 | 62135-480-42 | 100 mL in 1 BOTTLE (62135-480-42) |
| CEPHALEXIN | cephalexin | FOR SUSPENSION;ORAL | 065336 | ANDA | Chartwell RX, LLC | 62135-480 | 62135-480-49 | 200 mL in 1 BOTTLE (62135-480-49) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 125MG BASE/5ML | ||||
| Approval Date: | Jul 25, 2007 | 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: | Jul 25, 2007 | TE: | AB | RLD: | No | ||||
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