Application 208170
- Type
- ANDA
- Sponsor
- RUBICON
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 | 7.5MG | No | No |
| 003 | 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 |
|---|---|---|---|---|---|---|---|
| A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | |
| A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | |
| A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A208170-001 | AB |
| A208170-002 | AB |
| A208170-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208170-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-05-31 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208170-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | RS | 2017-05-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208170-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2017-05-31 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208170-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208170-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A208170-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A208170-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208170-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A208170-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A208170-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208170-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A208170-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208170-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208170-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208170-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A208170-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208170-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A208170-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208170-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208170-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208170-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208170-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208170-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208170-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208170-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208170-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208170-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208170-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208170-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208170-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208170-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208170-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208170-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208170-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208170-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208170-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208170-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208170-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208170-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208170-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208170-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208170-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208170-001 | AB | 1 | 301d65b070ca… |
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 | Bryant Ranch Prepack | 05641925-7b10-4b30-b6e8-44b416a5e77e | 2025-02-03 | Warnings, Adverse reactions | 208170 ANDA208170 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 96207b29-033b-46a3-961f-e5125288d50f | 2025-02-03 | Warnings, Adverse reactions | 208170 ANDA208170 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DirectRx | ceb56ab8-4a76-6dee-e053-2995a90aab30 | 2025-01-20 | Warnings, Adverse reactions | 208170 ANDA208170 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | a58cf759-048b-6740-e053-2a95a90a8b43 | 2025-01-17 | Warnings, Adverse reactions | 208170 ANDA208170 72189-080 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 01e18825-1cf9-a98c-e063-6294a90ae0a4 | 2025-01-14 | Warnings, Adverse reactions | 208170 ANDA208170 |
| Cyclobenzaprine HCL | CYCLOBENZAPRINE HCL | Advanced Rx of Tennessee, LLC | afca1267-4d8f-7453-e053-2995a90a865c | 2024-12-31 | Warnings, Adverse reactions | 208170 ANDA208170 |
| Cyclobenzaprine HCL | CYCLOBENZAPRINE HCL | Advanced Rx of Tennessee, LLC | afcab35f-4ab9-33a4-e053-2a95a90ad529 | 2024-12-31 | Warnings, Adverse reactions | 208170 ANDA208170 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8bdc725e-22e3-0f32-e053-2a95a90ae8a9 | 2024-06-14 | Warnings, Adverse reactions | 208170 ANDA208170 68071-4935 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | A-S Medication Solutions | d64ca498-81c6-4e10-ba82-3a50ee47bcfc | 2024-05-29 | Warnings, Adverse reactions | 208170 ANDA208170 50090-4729 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 00dbe051-a392-e2c6-e063-6394a90ab7f3 | 2024-03-27 | Warnings, Adverse reactions | 208170 ANDA208170 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 0f8ba2c0-38e7-a536-e063-6294a90ace8d | 2024-03-26 | Warnings, Adverse reactions | 208170 ANDA208170 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | 34ff8a08-0177-451f-9dbc-e21582346196 | 2024-01-01 | Warnings, Adverse reactions | 208170 ANDA208170 71205-356 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 85128989-bfa3-4b82-94c1-f90b14ccd2f9 | 2023-10-18 | Warnings, Adverse reactions | 208170 ANDA208170 71335-1099 71335-1266 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | 88bdee56-d6d9-4f14-be77-1e6898ba36f5 | 2023-09-01 | Warnings, Adverse reactions | 208170 ANDA208170 71205-065 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | A-S Medication Solutions | b524d150-0a83-42d1-a884-b930e49760cd | 2023-02-06 | Warnings, Adverse reactions | 208170 ANDA208170 50090-4730 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 2a6b2ad9-307a-4976-98b7-1b96e0408da7 | 2022-09-14 | Warnings, Adverse reactions | 208170 ANDA208170 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Asclemed USA, Inc. | 751f0d33-ceff-40b0-9329-9125f176e06a | 2022-07-29 | Warnings, Adverse reactions | 208170 ANDA208170 |
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 |
|---|---|---|---|---|---|
| 45865-962 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | medsource pharmaceuticals | ANDA | Current |
| 50090-4722 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4722 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4727 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4727 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4729 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4730 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51655-427 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 52817-330 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-330 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-330 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-331 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-331 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-331 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-332 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-332 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 52817-332 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | TruPharma LLC | ANDA | Current |
| 60760-363 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-365 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-365 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-366 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park P | ANDA | Current |
| 60760-366 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-366 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-366 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-366 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-7939 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67296-1621 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1621 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1621 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2453 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2880 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4655 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceutuicals,Inc. | ANDA | Current |
| 68071-4655 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceutuicals,Inc. | ANDA | Current |
| 68071-4655 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceutuicals,Inc. | ANDA | Current |
| 68071-4935 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4935 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4951 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4951 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4951 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7445 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7445 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7445 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7445 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7536 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7536 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7536 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7536 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2611 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2611 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2611 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2611 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2788 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2788 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2788 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2788 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2788 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2788 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3356 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3356 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3415 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3415 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-221 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-221 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-442 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-442 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-065 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-065 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-065 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-356 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-356 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-356 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1099 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1099 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1266 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1293 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1293 | CYCLOBENZAPRINE HYDROCHLORIDE | cyclobenzaprine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-080 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-080 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-080 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 72189-080 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | DIRECT RX | ANDA | Current |