Application 077563
- Type
- ANDA
- Sponsor
- JUBILANT CADISTA
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 |
| 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 |
|---|---|---|---|---|---|---|---|
| A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | |
| A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | |
| A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077563-001 | AB |
| A077563-002 | AB |
| A077563-003 | 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 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077563-002 | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2006-04-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077563-003 | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2017-08-25 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077563-001 | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2006-04-19 | 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 | A077563-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077563-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077563-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077563-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077563-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077563-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077563-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077563-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077563-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077563-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077563-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077563-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077563-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077563-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077563-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077563-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077563-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077563-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077563-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077563-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077563-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077563-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077563-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077563-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077563-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077563-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077563-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077563-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077563-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077563-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077563-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077563-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077563-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077563-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077563-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077563-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077563-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077563-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077563-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077563-001 | 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 | Preferred Pharmaceuticals Inc. | 84be93c5-1526-465e-ab0b-c6d10ba1521d | 2026-07-15 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine HCL | CYCLOBENZAPRINE HCL | Direct_Rx | 55683c5c-0f86-9a26-e063-6294a90a8e8c | 2026-07-01 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Coupler LLC | 47d22c6d-49fb-f97c-e063-6294a90a6ba1 | 2026-01-07 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Doc Rx | 4c054230-1978-44d2-9467-ed1994619113 | 2025-10-31 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 3bddfe25-00ba-747f-e063-6394a90a9ce6 | 2025-08-08 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | SOLA Pharmaceuticals, LLC | db930d05-3f92-41f1-888c-301b2c4565e6 | 2025-07-30 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | AvKARE | a264ab9f-cc12-325f-e053-2a95a90a53d9 | 2025-07-24 | Warnings, Adverse reactions | 077563 ANDA077563 42291-154 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 34f4e63a-1259-0226-e063-6294a90a9fc4 | 2025-06-16 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | 3f1b9c8a-8f75-4b84-af0c-739815937fd7 | 2025-04-01 | Warnings, Adverse reactions | 077563 ANDA077563 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Bryant Ranch Prepack | dcef9b63-f998-4852-920d-c356623cea6a | 2025-03-21 | Warnings, Adverse reactions | 077563 ANDA077563 63629-2424 |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Jubilant Cadista Pharmaceuticals Inc. | 592871f6-0eb2-4624-9e10-bd8bf767c002 | 2025-02-21 | Warnings, Adverse reactions | 077563 ANDA077563 59746-735 59746-211 59746-177 |
| Cyclobenzaprine HCL | CYCLOBENZAPRINE HCL | Advanced Rx of Tennessee, LLC | afca2a49-6424-7b6a-e053-2a95a90ad41e | 2024-12-31 | Warnings, Adverse reactions | 077563 ANDA077563 80425-0017 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0179-0057 | cyclobenzaprine hydrochloride | cyclobenzaprine hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 0179-0189 | cyclobenzaprine hydrochloride | cyclobenzaprine hydrochloride | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 21695-036 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Rebel Distributors | ANDA | Current |
| 42291-154 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | AvKARE | ANDA | Current |
| 42291-154 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | AvKARE | ANDA | Current |
| 50090-4024 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4024 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4026 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4105 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4105 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4205 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5326 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5326 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-9804 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Unit Dose Services | ANDA | Current |
| 53808-1039 | cyclobenzaprine hydrochloride | cyclobenzaprine hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 59746-177 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-211 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 59746-735 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Jubilant Cadista Pharmaceuticals Inc. | ANDA | Current |
| 63629-2424 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2424 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67046-119 | cyclobenzaprine hydrochloride | cyclobenzaprine hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1763 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1763 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 71610-379 | Cyclobenzaprine Hydrochloride | Cyclobenzaprine Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 80425-0017 | Flexeril | Cyclobenzaprine HCl 5mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0017 | Cyclobenzaprine HCL | Cyclobenzaprine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0017 | Cyclobenzaprine HCL | Cyclobenzaprine HCL | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |