Application 201807
- 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, EXTENDED RELEASE;ORAL | 75MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 10544-935 | Indomethacin | Indomethacin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 31722-565 | Indomethacin | Indomethacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-565 | Indomethacin | Indomethacin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50090-2715 | Indomethacin | Indomethacin | A-S Medication Solutions | ANDA | Current |
| 50268-432 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 50268-432 | Indomethacin | Indomethacin | AvPAK | ANDA | Current |
| 61919-344 | INDOMETHACIN | INDOMETHACIN | Direct RX | ANDA | Current |
| 63629-1915 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 63629-1915 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 68071-3060 | Indomethacin | Indomethacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3060 | Indomethacin | Indomethacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3060 | Indomethacin | Indomethacin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70518-0515 | Indomethacin | Indomethacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0515 | Indomethacin | Indomethacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0515 | Indomethacin | Indomethacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0515 | Indomethacin | Indomethacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0515 | Indomethacin | Indomethacin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0515 | Indomethacin | Indomethacin | REMEDYREPACK INC. | ANDA | Current |
| 70934-031 | Indomethacin | Indomethacin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-031 | Indomethacin | Indomethacin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-031 | Indomethacin | Indomethacin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0756 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 71335-0756 | Indomethacin | Indomethacin | Bryant Ranch Prepack | ANDA | Current |
| 76420-029 | Indomethacin | Indomethacin | Asclemed USA, Inc. | ANDA | Current |
| 76420-029 | Indomethacin | Indomethacin | Asclemed USA, Inc. | ANDA | Current |