Application 077797
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | |
| A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077797-001 | AB |
| A077797-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2007-02-28 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2007-02-28 | bb7c543d1eb4… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077797-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A077797-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A077797-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077797-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077797-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077797-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077797-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077797-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077797-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077797-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077797-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077797-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077797-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077797-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077797-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077797-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A077797-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077797-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A077797-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A077797-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077797-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A077797-002 | AB | 1 | bb7c543d1eb4… |
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 |
|---|---|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 15c0c7aa-8c54-4040-a1bf-2a7b421ad33f | 2025-12-11 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 59b428fa-5013-4b2b-872f-16ba4a9d4f5d | 2025-05-01 | Warnings, Adverse reactions | 077797 ANDA077797 72789-115 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9161cb5e-63e5-41d7-9bde-66c7b7b7a2f3 | 2025-05-01 | Warnings, Adverse reactions | 077797 ANDA077797 72789-156 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3aaa4808-7f2d-410c-9b6c-193549ec0845 | 2025-04-30 | Warnings, Adverse reactions | 077797 ANDA077797 72789-036 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7829a96a-3668-4d88-90e9-0ecbedb2bd7e | 2025-04-30 | Warnings, Adverse reactions | 077797 ANDA077797 72789-046 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 3baeda95-d098-437a-b360-87a9c3f3fd9b | 2025-04-30 | Warnings, Adverse reactions | 077797 ANDA077797 72789-073 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | aa29e260-fb77-415a-a505-3230d30c8945 | 2025-02-10 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | afcad582-ab59-4f70-e053-2a95a90a04e4 | 2024-12-31 | Warnings, Adverse reactions | 077797 ANDA077797 80425-0019 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 4c51f56b-33c3-4611-bba8-876d9dde7aff | 2024-11-27 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 90c7a982-6442-4241-a60b-b5dfab2abb71 | 2024-01-31 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | c86303a0-7c8b-415e-acac-1070b7d0d445 | 2024-01-15 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 68db3c3b-8da1-4852-90b0-3172f842aa02 | 2023-03-02 | Warnings, Adverse reactions | 077797 ANDA077797 76420-033 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Solco Healthcare U.S., LLC | f558863b-ea3f-4e4b-85e9-edb2573e7151 | 2022-08-22 | Warnings, Adverse reactions | 077797 ANDA077797 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | be5201bc-e1f1-41af-be46-4a8fbb223b86 | 2020-05-27 | Warnings, Adverse reactions | 077797 ANDA077797 71610-428 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | 571fbb2b-24e0-4de3-8cfa-c267fc397b6c | 2019-10-01 | Warnings, Adverse reactions | 077797 ANDA077797 71205-201 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67296-1534 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1534 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1534 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68071-1983 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3377 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3377 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3390 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3390 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4076 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4076 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68258-7013 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 68788-6375 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7131 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7131 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7131 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7131 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9069 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70934-063 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Denton Pharma, Inc. | ANDA | Current |
| 70934-063 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-063 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Denton Pharma, Inc. | ANDA | Current |
| 71205-201 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-201 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-0921 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0921 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-428 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72789-036 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-036 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-036 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-036 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-036 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-036 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-046 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-073 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-073 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-073 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-073 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-115 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-115 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-115 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-115 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-156 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-156 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 76420-033 | Cyclobenzaprine Hydrochloride | cyclobenzaprine hydrochloride | Asclemed USA, Inc. | ANDA | Current |
| 80175-0400 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Central Packaging | ANDA | Current |
| 80175-0400 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Central Packaging | ANDA | Current |
| 80175-0400 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Central Packaging | ANDA | Current |
| 80425-0019 | Flexeril | Cyclobenzaprine HCl 10mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0019 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0019 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |