Application 065308
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | TABLET;ORAL | EQ 125MG BASE | No | No |
| 002 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | TABLET;ORAL | EQ 250MG BASE | No | No |
| 003 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | TABLET;ORAL | EQ 500MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-400 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 16714-400 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 16714-400 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 16714-400 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 16714-401 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 16714-401 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 16714-401 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 16714-401 | Cefuroxime Axetil | Cefuroxime Axetil | NorthStar Rx LLC | ANDA | Current |
| 21695-150 | Cefuroxime axetil | Cefuroxime axetil | Rebel Distributors Corp | ANDA | Current |
| 21695-370 | Cefuroxime axetil | Cefuroxime axetil | Rebel Distributors Corp | ANDA | Current |
| 43063-623 | Cefuroxime Axetil | Cefuroxime Axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-623 | Cefuroxime Axetil | Cefuroxime Axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-623 | Cefuroxime Axetil | Cefuroxime Axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-623 | Cefuroxime Axetil | Cefuroxime Axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-623 | Cefuroxime Axetil | Cefuroxime Axetil | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-0781 | Cefuroxime Axetil | Cefuroxime Axetil | A-S Medication Solutions | ANDA | Current |
| 50090-0781 | Cefuroxime Axetil | Cefuroxime Axetil | A-S Medication Solutions | ANDA | Current |
| 50090-4153 | Cefuroxime Axetil | Cefuroxime Axetil | A-S Medication Solutions | ANDA | Current |
| 52343-062 | Cefuroxime Axetil | Cefuroxime Axetil | LUCID PHARMA LLC | ANDA | Current |
| 52343-063 | Cefuroxime Axetil | Cefuroxime Axetil | LUCID PHARMA LLC | ANDA | Current |
| 52959-939 | Cefuroxime Axetil | Cefuroxime Axetil | H.J. Harkins Company, Inc. | ANDA | Current |
| 55700-436 | Cefuroxime Axetil | Cefuroxime Axetil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-436 | Cefuroxime Axetil | Cefuroxime Axetil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-436 | Cefuroxime Axetil | Cefuroxime Axetil | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 57237-058 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 57237-058 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 57237-058 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 57237-058 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 57237-059 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 57237-059 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 57237-059 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 57237-059 | Cefuroxime Axetil | Cefuroxime Axetil | Rising Health, LLC | ANDA | Current |
| 61919-044 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | DIRECT RX | ANDA | Current |
| 61919-044 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | DIRECT RX | ANDA | Current |
| 61919-145 | CEFUROXIME AXETIL | CEFUROXIME AXETIL | DIRECT RX | ANDA | Current |
| 65862-698 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-698 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-698 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-698 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-698 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-699 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-699 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-699 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-699 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-699 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-700 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-700 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-700 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-700 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 65862-700 | Cefuroxime Axetil | Cefuroxime Axetil | Aurobindo Pharma Limited | ANDA | Current |
| 68071-2879 | Cefuroxime Axetil | Cefuroxime Axetil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2879 | Cefuroxime Axetil | Cefuroxime Axetil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3000 | Cefuroxime Axetil | Cefuroxime Axetil | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3291 | Cefuroxime Axetil | Cefuroxime Axetil | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9914 | Cefuroxime Axetil | Cefuroxime Axetil | Preferred Pharmaceuticali Inc. | ANDA | Current |
| 70518-3215 | Cefuroxime Axetil | Cefuroxime Axetil | REMEDYREPACK INC. | ANDA | Current |
| 70934-088 | Cefuroxime Axetil | Cefuroxime Axetil | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-088 | Cefuroxime Axetil | Cefuroxime Axetil | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-088 | Cefuroxime Axetil | Cefuroxime Axetil | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |