Application 091625
- Type
- ANDA
- Sponsor
- GRANULES INDIA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 400MG | No | No |
| 002 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 600MG | No | No |
| 003 | IBUPROFEN | IBUPROFEN | TABLET;ORAL | 800MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42708-006 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-006 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-006 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-121 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-121 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 42708-121 | Ibuprofen | Ibuprofen | QPharma Inc | ANDA | Current |
| 50090-2548 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2548 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2548 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2548 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2548 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2549 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2549 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2549 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2549 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2597 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2597 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2597 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2625 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2625 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2625 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2626 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2626 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2626 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2629 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2629 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2670 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-2996 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-3007 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-3007 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50090-3007 | Ibuprofen | Ibuprofen | A-S Medication Solutions | ANDA | Current |
| 50436-0319 | Ibuprofen | Ibuprofen | Unit Dose Services | ANDA | Current |
| 50436-0319 | Ibuprofen | Ibuprofen | Unit Dose Services | ANDA | Current |
| 50436-0321 | Ibuprofen | Ibuprofen | Unit Dose Services | ANDA | Current |
| 50436-0321 | Ibuprofen | Ibuprofen | Unit Dose Services | ANDA | Current |
| 50436-3200 | Ibuprofen | Ibuprofen | Unit Dose Services | ANDA | Current |
| 50436-3200 | Ibuprofen | Ibuprofen | Unit Dose Services | ANDA | Current |
| 51655-048 | Ibuprofen | Ibuprofen | Northwind Pharmaceuticals | ANDA | Current |
| 51655-048 | Ibuprofen | Ibuprofen | Northwind Pharmaceuticals | ANDA | Current |
| 51655-385 | Ibuprofen | Ibuprofen | Northwind Pharmaceuticals | ANDA | Current |
| 51655-385 | Ibuprofen | Ibuprofen | Northwind Pharmaceuticals | ANDA | Current |
| 53217-364 | Ibuprofen | Ibuprofen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 54348-825 | Ibuprofen | IBUPROFEN | PharmPak, Inc. | ANDA | Current |
| 54348-825 | Ibuprofen | IBUPROFEN | PharmPak, Inc. | ANDA | Current |
| 54348-830 | Ibuprofen | IBUPROFEN | PharmPak, Inc. | ANDA | Current |
| 54348-830 | Ibuprofen | IBUPROFEN | PharmPak, Inc. | ANDA | Current |
| 54348-835 | Ibuprofen | IBUPROFEN | PharmPak, Inc. | ANDA | Current |
| 54348-835 | Ibuprofen | IBUPROFEN | PharmPak, Inc. | ANDA | Current |
| 55700-445 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-445 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-445 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-445 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-445 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-445 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-446 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-446 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-446 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-446 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-446 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-446 | Ibuprofen | Ibuprofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-694 | Ibuprofen | Ibuprofen | Quality Care Products, LLC | ANDA | Current |
| 55700-694 | Ibuprofen | Ibuprofen | Quality Care Products, LLC | ANDA | Current |
| 55700-694 | Ibuprofen | Ibuprofen | Quality Care Products, LLC | ANDA | Current |
| 55700-694 | Ibuprofen | Ibuprofen | Quality Care Products, LLC | ANDA | Current |
| 59088-756 | IBUPAK | Ibuprofen | PureTek Corporation | ANDA | Current |
| 60760-374 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-375 | Ibuprofen | Ibuprofen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-463 | IBUPROFEN | IBUOROFEN | DIRECT RX | ANDA | Current |
| 61919-463 | IBUPROFEN | IBUOROFEN | DIRECT RX | ANDA | Current |
| 61919-463 | IBUPROFEN | IBUOROFEN | Direct_Rx | ANDA | Current |
| 61919-463 | IBUPROFEN | IBUOROFEN | Direct_Rx | ANDA | Current |
| 61919-463 | IBUPROFEN | IBUOROFEN | Direct_Rx | ANDA | Current |
| 61919-628 | IBUPROFEN | IBUPROFEN | Direct_Rx | ANDA | Current |
| 61919-628 | IBUPROFEN | IBUPROFEN | Direct_Rx | ANDA | Current |
| 61919-628 | IBUPROFEN | IBUPROFEN | DIRECT RX | ANDA | Current |
| 61919-628 | IBUPROFEN | IBUPROFEN | Direct_Rx | ANDA | Current |
| 61919-683 | IBUPROFEN | IBUPROFEN | Direct_Rx | ANDA | Current |
| 61919-683 | IBUPROFEN | IBUPROFEN | Direct_Rx | ANDA | Current |
| 61919-683 | IBUPROFEN | IBUPROFEN | Direct_Rx | ANDA | Current |
| 62207-354 | Ibuprofen | Ibuprofen | Granules India Limited | ANDA | Current |