Application 077214
- Type
- ANDA
- Sponsor
- ACME LABS
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 |
|---|---|---|---|---|---|---|---|
| A077214-001 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | |
| A077214-002 | ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077214-001 | AB |
| A077214-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077214-001 | ZOLPIDEM TARTRATE | 5MG | TABLET / ORAL | AB | 2007-04-23 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077214-002 | ZOLPIDEM TARTRATE | 10MG | TABLET / ORAL | AB | 2007-04-23 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077214-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077214-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077214-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077214-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077214-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077214-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077214-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077214-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077214-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077214-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077214-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077214-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077214-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077214-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077214-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077214-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077214-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077214-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077214-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077214-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077214-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077214-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077214-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077214-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077214-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077214-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077214-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077214-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077214-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077214-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077214-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077214-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077214-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077214-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077214-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077214-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077214-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077214-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077214-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A077214-002 | AB | 1 | 782e0a99824c… |
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 | Golden State Medical Supply, Inc. | 2b5cf535-ccdc-ecd7-e063-6394a90a726e | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | The ACME Laboratories Ltd. | 5679ed64-8424-4e63-a3c9-91d80fff2ca6 | 2026-03-04 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 3882d72d-686b-406b-e063-6294a90a0b89 | 2025-06-26 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| ZOLPIDEM TARTRATE | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 349053e4-9885-ec0b-e063-6294a90ad79a | 2025-05-23 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 1e15d6e3-8d06-0936-e063-6394a90ab8db | 2025-05-22 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 1e13ad50-f846-813a-e063-6294a90a5878 | 2024-09-29 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 8cef5718-c562-43c3-8abe-a2fc5235ad2a | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 63629-8998 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | fff2e7fc-2f7e-43c9-bfb3-d929ecc9eb72 | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 63629-1170 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 74c4e793-3444-4d3d-8211-26374349ab1e | 2024-08-28 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Advanced Rx of Tennessee, LLC | 1fa86b79-8809-35f4-e063-6394a90a4377 | 2024-08-13 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Golden State Medical Supply, Inc. | 1a8f7696-0d02-dd1f-e063-6394a90a5866 | 2024-07-23 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 70d7cfc3-7e54-4cd8-8911-7cf115d5c820 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 23bce69d-7918-42c2-8020-e22f292ff31f | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 3aa7e88b-7929-45ac-9e81-03f4abf28e94 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 63629-8999 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 1e5b61b6-a5bd-4f09-9d34-905ce32f1899 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | c6824c69-76bc-4ca0-a6b1-5cddc2c42fc9 | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 63629-1171 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | df130798-1458-455b-a4e1-c33c4ecee43b | 2023-12-27 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | Bryant Ranch Prepack | 33094305-4bbd-4b52-9079-8853d5f83682 | 2023-12-01 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 |
| Zolpidem | ZOLPIDEM TARTRATE | ACI Healthcare USA, Inc | 021153ce-fe27-4ed1-8d88-b4157b0ed734 | 2023-11-16 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 71093-156 71093-155 |
| Zolpidem | ZOLPIDEM TARTRATE | Aphena Pharma Solutions - Tennessee, LLC | 8581cfad-525b-4b16-b116-a5138d9fda52 | 2022-10-18 | Boxed warning, Warnings, Adverse reactions | 077214 ANDA077214 71610-670 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0086 | Zolpidem Tartrate | zolpidem tartrate | Roxane Laboratories, Inc | ANDA | Current |
| 0054-0087 | Zolpidem Tartrate | zolpidem tartrate | Roxane Laboratories, Inc | ANDA | Current |
| 50436-0009 | Zolpidem | Zolpidem Tartrate | Unit Dose Services | ANDA | Current |
| 63629-1170 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1170 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1171 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1171 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-1171 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8998 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8998 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8999 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8999 | Zolpidem | Zolpidem Tartrate | Bryant Ranch Prepack | ANDA | Current |
| 68071-2642 | Zolpidem | Zolpidem Tartrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2774 | Zolpidem | Zolpidem Tartrate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 70934-917 | Zolpidem | Zolpidem Tartrate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71093-155 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71093-155 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71093-155 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71093-155 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71093-156 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71093-156 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71093-156 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71093-156 | Zolpidem | Zolpidem Tartrate | ACI Healthcare USA, Inc | ANDA | Current |
| 71205-691 | Zolpidem | Zolpidem Tartrate | Proficient Rx LP | ANDA | Current |
| 71610-670 | Zolpidem | Zolpidem Tartrate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9018 | ORIG | 2007-05-01 |