Application 065253
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEPHALEXIN | CEPHALEXIN | CAPSULE;ORAL | EQ 250MG BASE | No | No |
| 002 | CEPHALEXIN | CEPHALEXIN | CAPSULE;ORAL | EQ 500MG BASE | No | No |
| 003 | CEPHALEXIN | CEPHALEXIN | CAPSULE;ORAL | EQ 750MG BASE | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0440-7244 | Cephalexin | Cephalexin | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 10544-004 | Cephalexin | Cephalexin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-142 | Cephalexin | Cephalexin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-316 | Cephalexin | Cephalexin | Rebel Distributors Corp. | ANDA | Current |
| 21695-317 | Cephalexin | Cephalexin | Rebel Distributors Corp. | ANDA | Current |
| 45865-428 | Cephalexin | Cephalexin | Medsource Pharmaceuticals | ANDA | Current |
| 45865-428 | Cephalexin | Cephalexin | Medsource Pharmaceuticals | ANDA | Current |
| 50090-0070 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-0070 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-0079 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 50090-0081 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 51655-026 | Cephalexin | Cephalexin | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 52343-001 | Cephalexin | Cephalexin | Gen-Source Rx | ANDA | Current |
| 52343-002 | Cephalexin | Cephalexin | Gen-Source Rx | ANDA | Current |
| 55700-043 | Cephalexin | Cephalexin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-145 | Cephalexin | Cephalexin | Quality Care Products, LLC | ANDA | Current |
| 65862-018 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-018 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-018 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-018 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-019 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-019 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-019 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 65862-019 | Cephalexin | Cephalexin | Aurobindo Pharma Limited | ANDA | Current |
| 66116-400 | Cephalexin | Cephalexin | MedVantx, Inc. | ANDA | Current |
| 66336-055 | Cephalexin | Cephalexin | Dispensing Solutions, Inc. | ANDA | Current |
| 68788-9404 | Cephalexin | Cephalexin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9404 | Cephalexin | Cephalexin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9404 | Cephalexin | Cephalexin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69043-008 | Cephalexin | Cephalexin | Cronus Pharma LLC | ANDA | Current |
| 69043-008 | Cephalexin | Cephalexin | Cronus Pharma LLC | ANDA | Current |
| 69043-009 | Cephalexin | Cephalexin | Cronus Pharma LLC | ANDA | Current |
| 69043-009 | Cephalexin | Cephalexin | Cronus Pharma LLC | ANDA | Current |
| 70518-3066 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3066 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3066 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3066 | Cephalexin | Cephalexin | REMEDYREPACK INC. | ANDA | Current |
| 70934-109 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-109 | Cephalexin | Cephalexin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 72287-310 | Cephalexin | Cephalexin | AMELLA PHARMA, LLC | ANDA | Current |
| 76413-142 | Cephalexin | Cephalexin | Central Texas Community Health Centers | ANDA | Current |
| 80425-0004 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |
| 80425-0004 | Cephalexin | Cephalexin | ADVANCED RX PHARMACY OF TENNESSEE, LLC | ANDA | Current |