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 8 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENCS HealthCare of KY, LLC dba Vangard Labs53688de9-2031-4d19-b422-4000285f7f472024-08-12Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1ac77323-7526-a129-e063-6394a90a641b2024-07-22Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8bdc725e-22e3-0f32-e053-2a95a90ae8a92024-06-14Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labse332763b-00c6-41bf-84ae-a07d9ef796972024-06-11Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.ca74d27a-f7c6-462d-a913-1cfa061bd8f32024-05-31Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEA-S Medication Solutionsd64ca498-81c6-4e10-ba82-3a50ee47bcfc2024-05-29Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.07e3ec53-f1f2-4231-aec6-1772a146ba882024-05-07Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
AMRIXCYCLOBENZAPRINE HYDROCHLORIDECephalon, LLC3902123b-1365-ac3c-0934-afff9eeeb1bd2024-04-30Warnings, Adverse reactionsName fallback
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.00dbe051-a392-e2c6-e063-6394a90ab7f32024-03-27Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0f8ba2c0-38e7-a536-e063-6294a90ace8d2024-03-26Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.c68d17e2-2311-8e17-e053-2995a90a565b2024-03-11Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEMedsource Pharmaceuticals12645f19-fffc-8b08-e063-6394a90a5c552024-02-27Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack90c7a982-6442-4241-a60b-b5dfab2abb712024-01-31Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackc86303a0-7c8b-415e-acac-1070b7d0d4452024-01-15Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP34ff8a08-0177-451f-9dbc-e215823461962024-01-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC31bb92f6-ec8c-4636-8b07-8814417fe78e2023-12-31Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack4a2d3cae-5c64-4986-9707-cc213b70b7ad2023-10-19Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack85128989-bfa3-4b82-94c1-f90b14ccd2f92023-10-18Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAsclemed USA, Inc.74af1727-e84f-4dad-82be-045e7d23beaf2023-09-06Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LP88bdee56-d6d9-4f14-be77-1e6898ba36f52023-09-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic 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