Application 216309
- Type
- ANDA
- Sponsor
- HERITAGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 0.5MG/ML | No | No |
| 002 | BACLOFEN | BACLOFEN | INJECTABLE;INTRATHECAL | 2MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A216309-001 | BACLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | ||
| A216309-002 | BACLOFEN | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 |
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 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | 2023-08-10 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | AP | 2023-08-10 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | AP | 2023-08-10 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216309-001 | BACLOFEN | 0.5MG/ML | INJECTABLE / INTRATHECAL | AP | 2023-08-10 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216309-002 | BACLOFEN | 2MG/ML | INJECTABLE / INTRATHECAL | AP | 2023-08-10 | a72a2bbeb626… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A216309-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A216309-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216309-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A216309-002 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216309-001 | AP | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A216309-002 | AP | 1 | 9b2671bbb829… |
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 | Sagent Pharmaceuticals | ea32c39c-0ee3-4b5e-8da7-4c31db334bd8 | 2021-06-24 | Boxed warning, Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Sagent Pharmaceuticals | 077aaf3b-1ca3-4599-a51a-6bbe39810ca8 | 2021-06-24 | Boxed warning, Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Lannett Company, Inc. | f84f3f4c-17e6-43f1-9600-63b0b175837b | 2021-02-24 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | 9edc00c6-c281-4e81-b176-44b7536f71f2 | 2020-08-13 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | d9e5a8b9-1524-41b4-942f-f95015dd17f9 | 2020-08-05 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Proficient Rx LP | 924a01fb-0ed0-4f73-9304-d6c5b9961d66 | 2020-05-01 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Teva Pharmaceuticals USA, Inc. | 5648c772-50cb-4961-996e-e68a8eb699ea | 2019-12-31 | Warnings, Adverse reactions | Baclofen BACLOFEN |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | dd4b9972-0295-4555-a90b-bb087170cfbb | 2017-12-07 | Warnings, Adverse reactions | Baclofen BACLOFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.