Application 017821
- Type
- NDA
- Sponsor
- JANSSEN RES AND DEV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017821-001 | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017821-002 | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 |
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| 2026-08 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017821-001 | FLEXERIL | 5MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017821-002 | FLEXERIL | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017821-001 | FLEXERIL | 5MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017821-002 | FLEXERIL | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017821-001 | FLEXERIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017821-002 | FLEXERIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… |
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 | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | REMEDYREPACK INC. | 51d85ea8-8317-4a76-a108-20383f118ad4 | 2026-07-10 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | dfe7288c-a477-4f32-a9ab-00cc981a1a57 | 2026-07-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 16ed7d7e-862f-db36-e063-6394a90a02a5 | 2026-06-26 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 106d9730-5938-8f27-e063-6294a90adc68 | 2026-06-23 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | fe81c68d-a579-4fe9-e053-6294a90a7bc0 | 2026-05-29 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Major Pharmaceuticals | 508e310e-067a-4f95-869a-e1da49aabe94 | 2026-05-21 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | ST. MARY'S MEDICAL PARK PHARMACY | 00b20a8c-debd-e930-e063-6394a90a7ed0 | 2026-05-20 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 1d9e34cc-eee9-4147-abf8-c810a80e39d2 | 2026-05-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Proficient Rx LP | ae3a3f5c-fb64-4a43-be88-a2fc7c298ac1 | 2026-05-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Coupler LLC | 5023b8a5-c9df-84a4-e063-6294a90a9606 | 2026-04-23 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | QPharma, Inc. | 4dcbdf8f-37ce-0f90-e063-6394a90ae83c | 2026-04-10 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 2f89c8f6-7f3c-8396-e063-6294a90a643e | 2026-04-06 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Sportpharm LLC | 24653b10-bdf0-47c5-a1f4-dc25f3b86032 | 2026-04-03 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 348c7ad4-b380-4b78-88f4-106b94079f52 | 2026-04-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 550d3e5a-c95f-4094-a500-1a02ea35a18d | 2026-04-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e4e8bab3-c5e7-4d2b-9692-ee6c6799b120 | 2026-04-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine Hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 014dd648-5b84-4d1d-80fc-a467e2d741ef | 2026-04-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| Cyclobenzaprine hydrochloride | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | ac8ae965-af50-41d3-8df5-ca6daf4bbd1c | 2026-04-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | e343fd12-1ca2-418a-b690-f3e8f567596d | 2026-04-01 | Warnings, Adverse reactions | CYCLOBENZAPRINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.