Application 091240
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | INDOMETHACIN | INDOMETHACIN | CAPSULE;ORAL | 25MG | No | No |
| 002 | INDOMETHACIN | INDOMETHACIN | CAPSULE;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-542 | Indomethacin | Indomethacin | Camber Pharmaceuticals | ANDA | Current |
| 31722-542 | Indomethacin | Indomethacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-542 | Indomethacin | Indomethacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-543 | Indomethacin | Indomethacin | Camber Pharmaceuticals | ANDA | Current |
| 31722-543 | Indomethacin | Indomethacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-543 | Indomethacin | Indomethacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 43063-773 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-773 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-773 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-773 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-773 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-773 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-777 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-777 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-777 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-777 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-777 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-883 | Indomethacin | Indomethacin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-0050 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0050 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0050 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0050 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0051 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0051 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0051 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0052 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0052 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0053 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50090-0053 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50268-430 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-430 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-430 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-430 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-431 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-431 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-431 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-431 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50436-0875 | Indomethacin | Indomethacin | Unit Dose Services | ANDA | Current |
| 51655-963 | Indomethacin | Indomethacin | Northwind Pharmaceuticals | ANDA | Current |
| 52959-081 | INDOMETHACIN | INDOMETHACIN | H.J. Harkins Co., Inc. | ANDA | Current |
| 53002-3050 | Indomethacin | Indomethacin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3050 | Indomethacin | Indomethacin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-536 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-536 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-536 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-536 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-536 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-537 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-537 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-537 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-537 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-537 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-537 | Indomethacin | Indomethacin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-129 | INDOMETHACIN | INDOMETHACIN | Direct Rx | ANDA | Current |
| 61919-129 | INDOMETHACIN | INDOMETHACIN | Direct Rx | ANDA | Current |
| 61919-130 | INDOMETHACIN | INDOMETHACIN | DIRECT RX | ANDA | Current |
| 61919-130 | INDOMETHACIN | INDOMETHACIN | Direct_Rx | ANDA | Current |
| 61919-130 | INDOMETHACIN | INDOMETHACIN | Direct_Rx | ANDA | Current |
| 61919-130 | INDOMETHACIN | INDOMETHACIN | DIRECT RX | ANDA | Current |
| 63187-282 | Indomethacin | Indomethacin | Proficient Rx LP | ANDA | Current |
| 63187-282 | Indomethacin | Indomethacin | Proficient Rx LP | ANDA | Current |
| 63629-1913 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-1913 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-1914 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-1914 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6333 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6333 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-7171 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-7171 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-7171 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-7171 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8066 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8066 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8993 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8994 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 65977-5042 | Indomethacin | Indomethacin | Hetero Drugs Ltd., | ANDA | Current |
| 65977-5043 | Indomethacin | Indomethacin | Hetero Drugs Ltd., | ANDA | Current |
| 66267-119 | Indomethacin | Indomethacin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-119 | Indomethacin | Indomethacin | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-120 | Indomethacin | Indomethacin | NuCare Pharmaceuticals, I | ANDA | Current |