Application 206703

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206703-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24
A206703-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2484e616aacf4f…
2026-09-14 22:38:342026-08A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2484e616aacf4f…
2026-08-18 06:07:402026-07A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24caaa826d4ba7…
2026-08-18 06:07:402026-07A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORAL2018-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206703-001CYCLOBENZAPRINE HYDROCHLORIDE15MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206703-002CYCLOBENZAPRINE HYDROCHLORIDE30MGCAPSULE, EXTENDED RELEASE / ORALAB2018-07-2474a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206703-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206703-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206703-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206703-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206703-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206703-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206703-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206703-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206703-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206703-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206703-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206703-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206703-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206703-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A206703-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A206703-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206703-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A206703-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206703-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A206703-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206703-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A206703-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A206703-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A206703-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206703-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A206703-002AB1ea99ee380514…
2023-01-26 05:58 UTC2023-01A206703-001AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A206703-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206703-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206703-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206703-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A206703-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206703-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A206703-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206703-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206703-002AB1cb3db0bc1861…

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.

Matched openFDA labels page 4 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCc29cf8bd-2f63-ed4b-e053-2995a90ab6eb2026-01-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCdae3be94-a40c-5be1-e053-2a95a90a14842026-01-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENorthwind Health Company, LLCe04eea45-12ec-4d2b-e053-2a95a90a6b762026-01-01Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCf32bceda-1d24-322d-e053-2995a90aae1b2026-01-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLCf708cf0f-8373-14a2-e053-6394a90ab3fe2026-01-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENorthwind Health Company, LLC1912d134-a909-5511-e063-6294a90aea292025-12-26Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEMacleods Pharmaceuticals Limited1af467cb-7b21-4084-bb54-4634e928b1672025-12-26Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEGolden State Medical Supply, Inc.15c0c7aa-8c54-4040-a1bf-2a7b421ad33f2025-12-11Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions81917fa4-c79c-46e2-bfbb-507fc0d7ed1b2025-12-04Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.43ce2c79-ec4a-5120-e063-6394a90af6e12025-12-03Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEQPharma Incfbe6ba88-0581-50ef-e053-6394a90ab0862025-12-02Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions6b06b11c-0546-4f6e-9509-ba612bbcb9fd2025-11-19Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsf3187074-6b55-44a3-b969-40a808eb034a2025-11-19Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsbf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba2025-11-19Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutions1cb40f47-7fbb-4537-922d-04a08dd921c52025-11-19Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAmerican Health Packaging269bc278-963d-4830-816a-39bb4bf8c9362025-11-13Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPHOENIX RX LLC4383b26f-c39f-3d6a-e063-6294a90aba032025-11-13Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDoc Rx4c054230-1978-44d2-9467-ed19946191132025-10-31Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvPAK64f6d1be-4067-a5c7-2343-4aed651a0cac2025-10-28Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINEAvPAKe530fd1e-06fd-0432-e053-2995a90adf5f2025-10-28Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-3972Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent
60505-3972Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent
60505-3973Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent
60505-3973Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideApotex Corp.ANDACurrent