Application 076847
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 100MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-872 | Sumatriptan Succinate | Sumatriptan Succinate | Rebel Distributors Corp | ANDA | Current |
| 21695-873 | Sumatriptan Succinate | Sumatriptan Succinate | Rebel Distributors Corp | ANDA | Current |
| 21695-874 | Sumatriptan Succinate | Sumatriptan Succinate | Rebel Distributors Corp | ANDA | Current |
| 35356-438 | Sumatriptan Succinate | Sumatriptan Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-438 | Sumatriptan Succinate | Sumatriptan Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-438 | Sumatriptan Succinate | Sumatriptan Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-438 | Sumatriptan Succinate | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 35356-439 | Sumatriptan Succinate | Sumatriptan Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-439 | Sumatriptan Succinate | Sumatriptan Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-439 | Sumatriptan Succinate | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 45865-570 | Sumatriptan Succinate | Sumatriptan Succinate | Medsource Pharmaceuticals | ANDA | Current |
| 45865-570 | Sumatriptan Succinate | Sumatriptan Succinate | Medsource Pharmaceuticals | ANDA | Current |
| 50090-1765 | Sumatriptan Succinate | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-2916 | Sumatriptan Succinate | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50436-4624 | Sumatriptan Succinate | Sumatriptan Succinate | Unit Dose Services | ANDA | Current |
| 52959-510 | Sumatriptan Succinate | Sumatriptan Succinate | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-1592 | Sumatriptan Succinate | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1592 | Sumatriptan Succinate | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1593 | Sumatriptan Succinate | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1593 | Sumatriptan Succinate | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2562 | Sumatriptan Succinate | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55111-291 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-291 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-291 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-292 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-292 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-292 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-293 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-293 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-293 | Sumatriptan Succinate | Sumatriptan Succinate | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55700-235 | Sumatriptan Succinate | Sumatriptan Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-049 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-049 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-049 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-607 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-607 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-617 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-617 | Sumatriptan Succinate | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 68071-2283 | Sumatriptan Succinate | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2283 | Sumatriptan Succinate | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4562 | Sumatriptan Succinate | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4562 | Sumatriptan Succinate | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4562 | Sumatriptan Succinate | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-9004 | Sumatriptan Succinate | Sumatriptan Succinate | Preferred Pharmaceuticals | ANDA | Current |
| 68788-9005 | Sumatriptan Succinate | Sumatriptan Succinate | Preferred Pharmaceuticals | ANDA | Current |
| 70518-2859 | Sumatriptan Succinate | Sumatriptan Succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-2859 | Sumatriptan Succinate | Sumatriptan Succinate | REMEDYREPACK INC. | ANDA | Current |
| 76420-093 | Sumatriptan Succinate | Sumatriptan Succinate | Asclemed USA, Inc. | ANDA | Current |