Application 078148
- Type
- ANDA
- Sponsor
- ANCHEN PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 12.5MG | No | No |
| 002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | TABLET, EXTENDED RELEASE;ORAL | 6.25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078148-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | ||
| A078148-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 |
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 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | 2010-12-03 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | 2011-04-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-001 | ZOLPIDEM TARTRATE | 12.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-12-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-002 | ZOLPIDEM TARTRATE | 6.25MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-04-14 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078148-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078148-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078148-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078148-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A078148-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A078148-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A078148-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A078148-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078148-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078148-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A078148-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A078148-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A078148-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A078148-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A078148-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A078148-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A078148-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A078148-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A078148-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A078148-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A078148-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A078148-002 | AB | 1 | ea99ee380514… |
| 2023-05-13 08:27 UTC | 2023-05 | A078148-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A078148-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A078148-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A078148-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078148-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078148-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A078148-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A078148-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A078148-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A078148-002 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078148-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A078148-002 | AB | 1 | cb3db0bc1861… |
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 | Direct_Rx | 907c7b18-2638-512c-e053-2995a90ae6fd | 2026-01-08 | Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Northwind Health Company, LLC | 47212207-52a1-938b-e063-6294a90abca8 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Northwind Health Company, LLC | 26e20f53-c042-eac0-e063-6394a90acfca | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Lupin Pharmaceuticals, Inc. | ac647afe-2fe5-4056-806f-abdd54789b45 | 2025-12-26 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | 91511d2f-7066-49a0-90ea-2940d955c85e | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | A-S Medication Solutions | ef72eb73-d058-4ca3-9013-691aae8426fb | 2025-11-26 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| zolpidem tartrate | ZOLPIDEM TARTRATE | Golden State Medical Supply, Inc. | 41124767-8ff7-da5d-e063-6394a90a5203 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | zolpidem tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 8425be72-2bbe-4090-b00e-610f1a1646b1 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Cardinal Health 107, LLC | 83510333-f07d-4b81-a3ae-2801d114bd31 | 2025-10-30 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| zolpidem tartrate | ZOLPIDEM TARTRATE | Almatica Pharma LLC | 2f1a3600-9bd6-3651-3ab5-1e4e0b0a3916 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | zolpidem tartrate ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Preferred Pharmaceuticals, Inc. | a9ac3d4e-f502-41e3-95c0-0d334584566d | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Preferred Pharmaceuticals Inc. | 76ff87e4-3aa2-439d-8436-d9e6affb33c8 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Preferred Pharmaceuticals, Inc.. | 72e19b8e-d13a-4824-aee4-11778eba552c | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Preferred Pharmaceuticals Inc. | 625fad5b-8817-4773-a2fc-20b662140e6e | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 028bf425-7a72-464d-a242-aa5deee1ac23 | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | ST. MARY'S MEDICAL PARK PHARMACY | 3bc8a122-aa21-212c-e063-6394a90a3bda | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Asclemed USA, Inc. | 9922ce14-b418-4235-9c59-d674a8e70210 | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 3882d72d-686b-406b-e063-6294a90a0b89 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | a1faca42-6e46-4586-97ac-050b724e7d2a | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Proficient Rx LP | 92c58053-7ed8-4a3d-a2f7-8e30c4e5a367 | 2025-06-01 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
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 |
|---|---|---|---|---|---|
| 10370-116 | Zolpidem Tartrate | Zolpidem Tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-116 | Zolpidem Tartrate | Zolpidem Tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-116 | Zolpidem Tartrate | Zolpidem Tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-117 | Zolpidem Tartrate | Zolpidem Tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-117 | Zolpidem Tartrate | Zolpidem Tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 10370-117 | Zolpidem Tartrate | Zolpidem Tartrate | Par Pharmaceutical, Inc. | ANDA | Current |
| 50090-3994 | Zolpidem Tartrate | Zolpidem Tartrate | A-S Medication Solutions | ANDA | Current |
| 50436-0116 | Zolpidem Tartrate | Zolpidem Tartrate | Unit Dose Services | ANDA | Current |
| 51407-554 | Zolpidem Tartrate | Zolpidem Tartrate | Golden State Medical Supply | ANDA | Current |
| 51407-555 | Zolpidem Tartrate | Zolpidem Tartrate | Golden State Medical Supply | ANDA | Current |
| 55700-777 | Zolpidem Tartrate | Zolpidem Tartrate | Quality Care Products, LLC | ANDA | Current |
| 55700-777 | Zolpidem Tartrate | Zolpidem Tartrate | Quality Care Products, LLC | ANDA | Current |
| 60760-116 | Zolpidem Tartrate Extended Release | ZOLPIDEM TARTRATE | St Marys Medical Park Pharmacy | ANDA | Current |
| 71335-1801 | Zolpidem Tartrate | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1801 | Zolpidem Tartrate | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 71610-564 | Zolpidem Tartrate | Zolpidem Tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31338 | ORIG | 2010-12-07 |