Application 205606
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | ESOMEPRAZOLE MAGNESIUM | ESOMEPRAZOLE MAGNESIUM | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8396 | Esomeprazole Magnesium | Esomeprazole Magnesium | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-735 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 16714-736 | Esomeprazole Magnesium | Esomeprazole Magnesium | NorthStar Rx LLC | ANDA | Current |
| 45865-892 | Esomeprazole Magnesium | Esomeprazole Magnesium | medsourcer pharmaceuticals | ANDA | Current |
| 55700-889 | Esomeprazole Magnesium | Esomeprazole Magnesium | Quality Care Products, LLC | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-783 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 65862-784 | Esomeprazole Magnesium | Esomeprazole Magnesium | Aurobindo Pharma Limited | ANDA | Current |
| 68071-4212 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4457 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4536 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4536 | Esomeprazole Magnesium | Esomeprazole Magnesium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7201 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7201 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7201 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7326 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7623 | Esomeprazole Magnesium | Esomeprazole Magnesium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 71335-0807 | Esomeprazole Magnesium | Esomeprazole Magnesium | Bryant Ranch Prepack | ANDA | Current |
| 80425-0111 | Nexium | Esomeprazole Magnesium 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Nexium | Esomeprazole Magnesium 20mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Esomeprazole Magnesium | Esomeprazole Magnesium | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Esomeprazole Magnesium | Esomeprazole Magnesium | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0111 | Esomeprazole Magnesium | Esomeprazole Magnesium | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |