Application 077903
- Type
- ANDA
- Sponsor
- TORRENT PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;ORAL | 5MG | No | No |
| 002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077903-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | |
| A077903-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077903-001 | AB |
| A077903-002 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077903-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-08-17 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077903-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-08-17 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077903-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A077903-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A077903-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077903-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077903-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077903-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077903-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077903-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077903-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077903-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077903-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077903-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077903-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077903-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077903-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077903-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077903-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077903-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077903-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077903-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077903-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077903-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077903-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077903-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077903-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077903-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077903-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077903-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077903-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077903-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077903-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077903-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077903-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077903-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077903-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077903-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077903-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077903-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077903-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077903-002 | AB | 1 | 74a2ff9319b5… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | NuCare Pharmaceuticals, Inc | 4be6ce23-e7b1-510e-e054-00144ff8d46c | 2024-07-16 | Warnings, Adverse reactions | 077903 ANDA077903 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | DirectRX | 25f1176d-5195-1a99-e054-00144ff8d46c | 2024-06-26 | Warnings, Adverse reactions | 077903 ANDA077903 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | NuCare Pharmaceuticals,Inc. | 98e5208b-5109-58c6-e053-2995a90a994a | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 077903 ANDA077903 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | NuCare Pharmaceuticals,Inc. | 92c6cc45-c28b-729b-e053-2a95a90a7ccb | 2024-06-19 | Warnings, Adverse reactions | 077903 ANDA077903 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | NuCare Pharmaceuticals,Inc. | 78481108-4a1c-fce9-e053-2a91aa0a09ad | 2024-06-12 | Warnings, Adverse reactions | 077903 ANDA077903 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | A-S Medication Solutions | e68a1b3b-b3d1-495e-be46-466113e7dbd6 | 2023-09-14 | Boxed warning, Warnings, Adverse reactions | 077903 ANDA077903 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Proficient Rx LP | eaca34da-2b12-4dd4-91b5-a8446c7bd41e | 2022-07-01 | Warnings, Adverse reactions | 077903 ANDA077903 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Proficient Rx LP | e1f43bde-efba-42be-adef-94e1ef6664fd | 2022-04-01 | Warnings, Adverse reactions | 077903 ANDA077903 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6082 | ZOLPIDEM TARTRATE | zolpidem tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6082 | ZOLPIDEM TARTRATE | zolpidem tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6082 | ZOLPIDEM TARTRATE | zolpidem tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6083 | ZOLPIDEM TARTRATE | zolpidem tartrate | Major Pharmaceuticals | ANDA | Current |
| 0904-6083 | ZOLPIDEM TARTRATE | zolpidem tartrate | Major Pharmaceuticals | ANDA | Current |
| 13668-007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Torrent Pharmaceuticals Limited | ANDA | Current |
| 21695-506 | ZOLPIDEM TARTRATE | zolpidem tartrate | Rebel Distributors Corp. | ANDA | Current |
| 21695-507 | ZOLPIDEM TARTRATE | zolpidem tartrate | Rebel Distributors Corp. | ANDA | Current |
| 33261-172 | ZOLPIDEM TARTRATE | zolpidem tartrate | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-173 | ZOLPIDEM TARTRATE | zolpidem tartrate | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33358-420 | ZOLPIDEM TARTRATE | zolpidem tartrate | RxChange Co. | ANDA | Current |
| 33358-439 | ZOLPIDEM TARTRATE | zolpidem tartrate | RxChange Co. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-639 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-652 | ZOLPIDEM TARTRATE | zolpidem tartrate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-242 | ZOLPIDEM TARTRATE | zolpidem tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-242 | ZOLPIDEM TARTRATE | zolpidem tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-243 | ZOLPIDEM TARTRATE | zolpidem tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-243 | ZOLPIDEM TARTRATE | zolpidem tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-409 | ZOLPIDEM TARTRATE | zolpidem tartrate | Medsource Pharmaceuticals | ANDA | Current |
| 45865-413 | ZOLPIDEM TARTRATE | zolpidem tartrate | Medsource Pharmaceuticals | ANDA | Current |
| 50090-1022 | ZOLPIDEM TARTRATE | zolpidem tartrate | A-S Medication Solutions | ANDA | Current |
| 50090-1022 | ZOLPIDEM TARTRATE | zolpidem tartrate | A-S Medication Solutions | ANDA | Current |
| 50090-1022 | ZOLPIDEM TARTRATE | zolpidem tartrate | A-S Medication Solutions | ANDA | Current |
| 50090-1023 | ZOLPIDEM TARTRATE | zolpidem tartrate | A-S Medication Solutions | ANDA | Current |
| 50090-1023 | ZOLPIDEM TARTRATE | zolpidem tartrate | A-S Medication Solutions | ANDA | Current |
| 50436-0007 | ZOLPIDEM TARTRATE | zolpidem tartrate | Unit Dose Services | ANDA | Current |
| 50436-0008 | ZOLPIDEM TARTRATE | zolpidem tartrate | Unit Dose Services | ANDA | Current |
| 52959-879 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | H.J Harkins Company Inc. | ANDA | Current |
| 52959-879 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | H. J. Harkins Co., Inc. | ANDA | Current |
| 52959-880 | ZOLPIDEM TARTRATE | zolpidem tartrate | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-1292 | ZOLPIDEM TARTRATE | zolpidem tartrate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1292 | ZOLPIDEM TARTRATE | zolpidem tartrate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5020 | ZOLPIDEM TARTRATE | zolpidem tartrate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-5020 | ZOLPIDEM TARTRATE | zolpidem tartrate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55154-1398 | ZOLPIDEM TARTRATE | zolpidem tartrate | Cardinal Health | ANDA | Current |
| 55154-1398 | ZOLPIDEM TARTRATE | zolpidem tartrate | Cardinal Health | ANDA | Current |
| 55154-1398 | ZOLPIDEM TARTRATE | zolpidem tartrate | Cardinal Health 107, LLC | ANDA | Current |
| 55700-268 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-268 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-268 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-357 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-357 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-357 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-357 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-357 | ZOLPIDEM TARTRATE | zolpidem tartrate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-288 | ZOLPIDEM TARTRATE | zolpidem tartrate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-288 | ZOLPIDEM TARTRATE | zolpidem tartrate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-288 | ZOLPIDEM TARTRATE | zolpidem tartrate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-515 | ZOLPIDEM TARTRATE | zolpidem tartrate | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-515 | ZOLPIDEM TARTRATE | zolpidem tartrate | St Marys Medical Park Pharmacy | ANDA | Current |
| 60760-515 | ZOLPIDEM TARTRATE | zolpidem tartrate | St Marys Medical Park Pharmacy | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23891 | ORIG | 2007-08-24 |