Application 209594
- Type
- ANDA
- Sponsor
- MYLAN LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 1MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209594-001 | BACLOFEN | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A209594-001 | AP |
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 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A209594-001 | BACLOFEN | 1MG/ML | INJECTABLE / INTRATHECAL | AP | 2018-03-06 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209594-001 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A209594-001 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A209594-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209594-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A209594-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209594-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209594-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209594-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209594-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209594-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209594-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209594-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209594-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209594-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209594-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A209594-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209594-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A209594-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A209594-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A209594-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A209594-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A209594-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209594-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A209594-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A209594-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A209594-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A209594-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A209594-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A209594-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209594-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A209594-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A209594-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209594-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209594-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209594-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209594-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A209594-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A209594-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209594-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A209594-001 | AP | 1 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b5fde991-7d12-4083-a3d6-363718f1f6a1 | 2024-08-16 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Zydus Lifesciences Limited | bb5c6faa-2933-44d1-8706-8302150be734 | 2024-08-12 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Zydus Pharmaceuticals (USA) Inc. | cfc49176-8d01-4c39-9319-604dd087065c | 2024-08-12 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | NuCare Pharmaceuticals,Inc. | b2be2e6c-a247-30f4-e053-2a95a90a6ccb | 2024-07-17 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Direct_rx | 1bf59c3b-f8eb-972e-e063-6394a90aeccc | 2024-06-28 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 9834e409-8633-4f99-8ac7-7fa298d01c44 | 2024-05-30 | Warnings, Adverse reactions | BACLOFEN BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | 19b049cf-56a4-aeaa-e063-6394a90a366d | 2024-05-30 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | adc072b9-e48b-470d-9eb1-fd7b52c1f122 | 2024-05-29 | Warnings, Adverse reactions | BACLOFEN BACLOFEN |
| BACLOFEN | BACLOFEN | TruPharma LLC | 68aa591e-ea98-4438-9a4a-4f7e9ea2b285 | 2024-04-17 | Warnings, Adverse reactions | BACLOFEN BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | d24135b3-e247-412f-a10b-ceecbdee3aef | 2024-04-02 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 80a4c6f7-4f02-493c-9263-62e1c90404ba | 2024-04-02 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| BACLOFEN | BACLOFEN | Rising Pharma Holdings, Inc. | 6eb46715-d72b-473f-b984-90024033d4a0 | 2024-03-01 | Warnings, Adverse reactions | BACLOFEN BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7f27f935-b1fa-4494-9014-7f62c59bb8e3 | 2024-01-30 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f | 2024-01-30 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 402a0a2b-95a6-4d22-bedf-826e1f1cd2c3 | 2024-01-11 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b4506087-be24-4e76-9fb8-b07805137072 | 2024-01-10 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 54bea140-c537-44a2-8d1d-bfb20471f4d8 | 2024-01-10 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 12d57610-8c70-4729-b358-56525613a29d | 2024-01-10 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | ff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb | 2024-01-09 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | c582972d-22ef-4326-b37f-adf2ca0b1875 | 2023-12-21 | Warnings, Adverse reactions | Baclofen BACLOFEN |
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 |
|---|---|---|---|---|---|
| 67457-563 | baclofen | baclofen | Mylan Institutional LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 53618 | ORIG | 2018-04-05 |