DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 065229
NDA 065229 describes CEPHALEXIN, which is a drug marketed by Alkem Labs Ltd, Apothecon, Aurobindo Pharma Ltd, Barr, Belcher Pharms, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Orchid Hlthcare, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Yung Shin Pharm, Hikma Pharms, and Vitarine, and is included in forty-nine NDAs. It is available from thirty-nine 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. Forty-one 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. Forty-one suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 065229
| Tradename: | CEPHALEXIN |
| Applicant: | Lupin |
| Ingredient: | cephalexin |
| Patents: | 0 |
| Therapeutic Class: | Antibacterials |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 065229
| Ingredient-type | Cephalosporins |
Medical Subject Heading (MeSH) Categories for 065229
Suppliers and Packaging for NDA: 065229
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | cephalexin | CAPSULE;ORAL | 065229 | ANDA | A-S Medication Solutions | 50090-0072 | N | 50090-0072-2 |
| CEPHALEXIN | cephalexin | CAPSULE;ORAL | 065229 | ANDA | A-S Medication Solutions | 50090-0072 | N | 50090-0072-4 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Nov 25, 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 25, 2005 | TE: | AB | RLD: | No | ||||
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