Application 077241
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BACLOFEN | BACLOFEN | TABLET;ORAL | 20MG | No | No |
| 002 | BACLOFEN | BACLOFEN | TABLET;ORAL | 10MG | No | No |
| 003 | BACLOFEN | BACLOFEN | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077241-001 | BACLOFEN | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | |
| A077241-002 | BACLOFEN | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | |
| A077241-003 | BACLOFEN | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077241-001 | AB |
| A077241-002 | AB |
| A077241-003 | 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 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-002 | BACLOFEN | 10MG | TABLET / ORAL | AB | 2007-07-06 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-003 | BACLOFEN | 5MG | TABLET / ORAL | AB | 2021-09-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077241-001 | BACLOFEN | 20MG | TABLET / ORAL | AB | 2005-12-20 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077241-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077241-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077241-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077241-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077241-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077241-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077241-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077241-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077241-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077241-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077241-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077241-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077241-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077241-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077241-001 | AB | 1 | 8072bd15b7f6… |
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 | Cardinal Health 107, LLC | 2278954a-7605-426a-ae85-1bf0a3117420 | 2026-04-22 | Warnings, Adverse reactions | 077241 ANDA077241 55154-7876 |
| Baclofen | BACLOFEN | Major Pharmaceuticals | ae732bdc-5178-4565-8219-d1787a5211a6 | 2026-01-09 | Warnings, Adverse reactions | 077241 ANDA077241 0904-6476 |
| Baclofen | BACLOFEN | PD-Rx Pharmaceuticals, Inc. | cfcf519f-5d15-431d-89c8-961a0c38ba60 | 2025-10-17 | Warnings, Adverse reactions | 077241 ANDA077241 43063-865 |
| Baclofen | BACLOFEN | Marlex Pharmaceuticals Inc | 1b0f50c8-62e3-414d-96d3-5fd16e8043ab | 2025-09-22 | Warnings, Adverse reactions | 077241 ANDA077241 10135-532 10135-533 |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | b4f2f888-979a-6f54-e053-2a95a90a95a3 | 2024-12-31 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Chartwell RX, LLC | 2a75db96-590a-43cf-aefb-3bbcb287dbf0 | 2024-10-10 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7f27f935-b1fa-4494-9014-7f62c59bb8e3 | 2024-01-30 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | b4506087-be24-4e76-9fb8-b07805137072 | 2024-01-10 | Warnings, Adverse reactions | 077241 ANDA077241 63629-2083 |
| Baclofen | BACLOFEN | Aphena Pharma Solutions - Tennessee, LLC | c582972d-22ef-4326-b37f-adf2ca0b1875 | 2023-12-21 | Warnings, Adverse reactions | 077241 ANDA077241 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 58816b46-28a5-48e2-b89d-98df65939386 | 2023-10-20 | Warnings, Adverse reactions | 077241 ANDA077241 71335-0103 |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 9110b1cb-8604-4824-9337-84b08d41dd3c | 2023-10-20 | Warnings, Adverse reactions | 077241 ANDA077241 63629-2084 |
| Baclofen | BACLOFEN | Lannett Company, Inc. | f84f3f4c-17e6-43f1-9600-63b0b175837b | 2021-02-24 | Warnings, Adverse reactions | 077241 ANDA077241 0527-1333 0527-1337 |
| Baclofen | BACLOFEN | Proficient Rx LP | 924a01fb-0ed0-4f73-9304-d6c5b9961d66 | 2020-05-01 | Warnings, Adverse reactions | 077241 ANDA077241 63187-280 63187-313 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1333 | Baclofen | baclofen | Lannett Company, Inc. | ANDA | Current |
| 0527-1337 | Baclofen | baclofen | Lannett Company, Inc. | ANDA | Current |
| 0527-1337 | Baclofen | baclofen | Lannett Company, Inc. | ANDA | Current |
| 0527-1337 | Baclofen | baclofen | Lannett Company, Inc. | ANDA | Current |
| 0527-1337 | Baclofen | baclofen | Lannett Company, Inc. | ANDA | Current |
| 0527-1337 | Baclofen | baclofen | Lannett Company, Inc. | ANDA | Current |
| 0527-1337 | Baclofen | baclofen | Lannett Company, Inc. | ANDA | Current |
| 0904-6476 | Baclofen | baclofen | Major Pharmaceuticals | ANDA | Current |
| 0904-6476 | Baclofen | baclofen | Major Pharmaceuticals | ANDA | Current |
| 0904-6476 | Baclofen | baclofen | Major Pharmaceuticals | ANDA | Current |
| 0904-6476 | Baclofen | baclofen | Major Pharmaceuticals | ANDA | Current |
| 0904-6476 | Baclofen | baclofen | Major Pharmaceuticals | ANDA | Current |
| 10135-532 | Baclofen | baclofen | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-532 | Baclofen | baclofen | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-533 | Baclofen | baclofen | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-533 | Baclofen | baclofen | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-533 | Baclofen | baclofen | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-533 | Baclofen | baclofen | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-533 | Baclofen | baclofen | Marlex Pharmaceuticals Inc | ANDA | Current |
| 43063-865 | Baclofen | baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-865 | Baclofen | baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-865 | Baclofen | baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-865 | Baclofen | baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-865 | Baclofen | baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-865 | Baclofen | baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-865 | Baclofen | baclofen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-355 | Baclofen | baclofen | Medsource Pharmaceuticals | ANDA | Current |
| 50090-2871 | Baclofen | baclofen | A-S Medication Solutions | ANDA | Current |
| 50090-2871 | Baclofen | baclofen | A-S Medication Solutions | ANDA | Current |
| 55154-7876 | Baclofen | baclofen | Cardinal Health, Inc. | ANDA | Current |
| 55154-7876 | Baclofen | baclofen | Cardinal Health, Inc. | ANDA | Current |
| 55154-7876 | Baclofen | baclofen | Cardinal Health 107, LLC | ANDA | Current |
| 55700-408 | Baclofen | baclofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-408 | Baclofen | baclofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-408 | Baclofen | baclofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-408 | Baclofen | baclofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-408 | Baclofen | baclofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-408 | Baclofen | baclofen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-095 | BACLOFEN | BACLOFEN | DIRECT RX | ANDA | Current |
| 61919-095 | BACLOFEN | BACLOFEN | Direct_Rx | ANDA | Current |
| 61919-095 | BACLOFEN | BACLOFEN | Direct_Rx | ANDA | Current |
| 61919-095 | BACLOFEN | BACLOFEN | Direct_Rx | ANDA | Current |
| 61919-095 | BACLOFEN | BACLOFEN | DIRECT RX | ANDA | Current |
| 63187-280 | Baclofen | baclofen | Proficient Rx LP | ANDA | Current |
| 63187-280 | Baclofen | baclofen | Proficient Rx LP | ANDA | Current |
| 63187-313 | Baclofen | baclofen | Proficient Rx LP | ANDA | Current |
| 63187-313 | Baclofen | baclofen | Proficient Rx LP | ANDA | Current |
| 63629-2083 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2083 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2084 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2084 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |
| 63629-2084 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |
| 63739-974 | Baclofen | baclofen | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-974 | Baclofen | baclofen | McKesson Corporation | ANDA | Current |
| 66267-872 | Baclofen | baclofen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-872 | Baclofen | baclofen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3001 | Baclofen | baclofen | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3001 | Baclofen | baclofen | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3001 | Baclofen | baclofen | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68084-855 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68084-855 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68084-855 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68084-855 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68084-868 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68084-868 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68084-868 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68084-868 | Baclofen | baclofen | American Health Packaging | ANDA | Current |
| 68788-6384 | Baclofen | baclofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6384 | Baclofen | baclofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6384 | Baclofen | baclofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6384 | Baclofen | baclofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6384 | Baclofen | baclofen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2173 | Baclofen | baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-2173 | Baclofen | baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-2173 | Baclofen | baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-2173 | Baclofen | baclofen | REMEDYREPACK INC. | ANDA | Current |
| 70518-2173 | Baclofen | baclofen | REMEDYREPACK INC. | ANDA | Current |
| 71335-0103 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |
| 71335-0103 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |
| 71335-0103 | Baclofen | baclofen | Bryant Ranch Prepack | ANDA | Current |