Application 203270
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 10MG | No | No |
| 002 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 20MG | No | No |
| 003 | OMEPRAZOLE | OMEPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 40MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-746 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-747 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 16714-748 | Omeprazole | Omeprazole | NorthStar Rx LLC | ANDA | Current |
| 50090-3060 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4209 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4932 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 50090-4932 | Omeprazole | Omeprazole | A-S Medication Solutions | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-160 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-161 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 57237-162 | Omeprazole | Omeprazole | Rising Health, LLC | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-001 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-002 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |
| 59651-003 | Omeprazole | Omeprazole | Aurobindo Pharma Limited | ANDA | Current |