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 | Aphena Pharma Solutions - Tennessee, LLC | 349053e4-9885-ec0b-e063-6294a90ad79a | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 1e15d6e3-8d06-0936-e063-6394a90ab8db | 2025-05-22 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | 3310d63e-d79a-175d-e063-6394a90a4270 | 2025-04-18 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Ambien | ZOLPIDEM TARTRATE | Sanofi-Aventis U.S. LLC | c36cadf4-65a4-4466-b409-c82020b42452 | 2025-04-15 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Asclemed USA, Inc. | 30c057fb-2e1b-4b9c-8c8a-79c322151e61 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Preferred Pharmaceuticals Inc. | d579c6ca-c820-49ff-92fb-2e6aaad3b052 | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Asclemed USA, Inc. | e5e2d31b-ce26-78b0-e053-2a95a90ac491 | 2025-02-09 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Ambien | ZOLPIDEM TARTRATE | Cosette Pharmaceuticals, Inc. | 747949c5-2c91-4909-8a07-71b6826f8e97 | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Ambien CR | ZOLPIDEM TARTRATE | Cosette Pharmaceuticals, Inc. | 2d934da3-bd77-4470-e063-6294a90a64f5 | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | PD-Rx Pharmaceuticals, Inc. | 38c838a4-9943-445a-8e80-e823d56eeaa5 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | PD-Rx Pharmaceuticals, Inc. | fda413e7-b1ae-312a-e053-6394a90ab2c6 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | DIRECT RX | c3f23bc3-595b-28e5-e053-2a95a90a9c2c | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | ZOLPIDEM TARTRATE ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | NuCare Pharmaceuticals, Inc. | 2b9f696a-b637-4dea-e063-6394a90aeb2e | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | af87ae17-a3c5-a3a5-e053-2a95a90aa4b0 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | af87b722-cdb7-0b17-e053-2a95a90a315b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | af87df4e-2c97-e23e-e053-2a95a90ab354 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | b2db3979-daa6-6e83-e053-2a95a90a3a2f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx Pharmacy of Tennessee, LLC | c8adec28-9dcd-4a7e-e053-2a95a90a991e | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx Pharmacy of Tennessee, LLC | c859c752-8a85-2017-e053-2a95a90a771f | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Zolpidem Tartrate ZOLPIDEM TARTRATE |
| Zolpidem Tartrate | ZOLPIDEM TARTRATE | Advanced Rx Pharmacy of Tennessee, LLC | fc76ab4c-3607-39c3-e053-6394a90a6877 | 2024-12-31 | 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 |