Application 071611
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | |
| A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | |
| A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071611-001 | AB |
| A071611-002 | AB |
| A071611-003 | 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 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071611-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-02-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071611-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2006-02-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A071611-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 1989-05-03 | 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 | A071611-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071611-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071611-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071611-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071611-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071611-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071611-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071611-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071611-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071611-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071611-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071611-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071611-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071611-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071611-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071611-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071611-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071611-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071611-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071611-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071611-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071611-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071611-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071611-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071611-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071611-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071611-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071611-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071611-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071611-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071611-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071611-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071611-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071611-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071611-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071611-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071611-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071611-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071611-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A071611-001 | 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 |
|---|---|---|---|---|---|---|
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 1d9e34cc-eee9-4147-abf8-c810a80e39d2 | 2026-06-15 | Warnings, Adverse reactions | 071611 ANDA071611 0093-3421 0093-3422 0093-3420 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1ac77323-7526-a129-e063-6394a90a641b | 2024-07-22 | Warnings, Adverse reactions | 071611 ANDA071611 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | f8dec4e2-3151-4a79-b194-a11a57ada0b6 | 2022-09-03 | Warnings, Adverse reactions | 071611 ANDA071611 76420-268 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-3420 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3421 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-3422 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0440-1350 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-7350 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0591-3256 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3256 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3256 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3330 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3330 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3330 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-3330 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5658 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5658 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0591-5658 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Actavis Pharma, Inc. | ANDA | Current |
| 0904-7809 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 10544-072 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-830 | Fexmid | cyclobenzaprine hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 42708-081 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-081 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-106 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | QPharma Inc | ANDA | Current |
| 42708-106 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | QPharma Inc | ANDA | Current |
| 50090-2862 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3163 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3167 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3290 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3329 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3728 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5895 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5896 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5897 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5900 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-0950 | Fexmid | Cyclobenzaprine Hydrochloride | Unit Dose Services | ANDA | Current |
| 51655-440 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53002-0522 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53149-4842 | Cyclobenzaprine | Cyclobenzaprine Hydrochloride | All Pharma, LLC | ANDA | Current |
| 53149-4850 | Fexmid | Cyclobenzaprine Hydrochloride | All Pharma, LLC | ANDA | Current |
| 53149-4850 | Fexmid | Cyclobenzaprine Hydrochloride | All Pharma, LLC | ANDA | Current |
| 53149-4851 | Fexmid | Cyclobenzaprine Hydrochloride | All Pharma, LLC | ANDA | Current |
| 55154-7884 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7884 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Cardinal Health | ANDA | Current |
| 55700-726 | Fexmid | Cyclobenzaprine Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 57237-266 | Cyclobenzaprine | Cyclobenzaprine Hydrochloride | Rising Health, LLC | ANDA | Current |
| 57237-266 | Cyclobenzaprine | Cyclobenzaprine Hydrochloride | Citron Pharma LLC | ANDA | Current |
| 60429-052 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-052 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 63187-011 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-011 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-380 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-380 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-7803 | Fexmid | Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7803 | Fexmid | Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7803 | Fexmid | Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 66336-581 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Dispensing Solutions, Inc. | ANDA | Current |
| 67296-0007 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67544-251 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 67544-251 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 68071-2596 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4502 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4502 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4502 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4826 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4826 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68387-500 | Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Keltman Pharmaceuticals Inc. | ANDA | Current |
| 68387-502 | Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Keltman Pharmaceuticals Inc. | ANDA | Current |
| 69176-300 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | TMIG Inc | ANDA | Current |
| 70199-014 | Fexmid | Cyclobenzaprine Hydrochloride | Casper Pharma LLC | ANDA | Current |
| 70518-0301 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-253 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-383 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-383 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-059 | Fexmid | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-059 | Fexmid | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-059 | Fexmid | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-059 | Fexmid | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-059 | Fexmid | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-897 | Cyclobenzaprine | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-897 | Cyclobenzaprine | Cyclobenzaprine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1253 | Fexmid | Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 76420-268 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Asclemed USA, Inc. | ANDA | Current |