Application 073541

Type
ANDA
Sponsor
ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A073541-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23
A073541-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A073541-001AB
A073541-002AB

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073541-001CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB1995-05-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A073541-002CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073541-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073541-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073541-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073541-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073541-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073541-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073541-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073541-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073541-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073541-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073541-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073541-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073541-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073541-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073541-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073541-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073541-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A073541-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A073541-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A073541-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A073541-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A073541-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A073541-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A073541-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A073541-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A073541-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A073541-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A073541-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A073541-002AB1782e0a99824c…

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 1 of 10 · 182 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.f2eb32c3-3da0-4938-9ed9-ea8420450fde2026-07-27Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETruPharma LLC08adc97f-feef-46fb-ac75-f015b4f3a43a2026-07-17Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4ee4feec-4590-fa7f-e063-6394a90a55502026-07-17Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.84be93c5-1526-465e-ab0b-c6d10ba1521d2026-07-15Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.51d85ea8-8317-4a76-a108-20383f118ad42026-07-10Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.34e57aff-dc4b-4631-9d57-31020244835d2026-07-08Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINECipla USA Inc.575a31fb-04c5-4001-88a7-c33adbacc6a82026-07-08Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEHAWAII REPACK, INC.cf5d4de9-79c3-4935-be69-89e98d7b54cc2026-07-03Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPdfe7288c-a477-4f32-a9ab-00cc981a1a572026-07-01Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy16ed7d7e-862f-db36-e063-6394a90a02a52026-06-26Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
TONMYACYCLOBENZAPRINE HYDROCHLORIDETonix Medicines, Inc.6fa59588-ce9b-48cf-8c5f-725a448f85712026-06-24Warnings, Adverse reactionsName fallback
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.106d9730-5938-8f27-e063-6294a90adc682026-06-23Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.1d9e34cc-eee9-4147-abf8-c810a80e39d22026-06-15Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.5d536e88-62be-45bd-bd09-0efc53fe12b92026-06-09Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEUnit Dose Solutions, Inc.53bef1ab-55c0-cc52-e063-6394a90a12b32026-06-08Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACYfe81c68d-a579-4fe9-e053-6294a90a7bc02026-05-29Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEMajor Pharmaceuticals508e310e-067a-4f95-869a-e1da49aabe942026-05-21Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY00b20a8c-debd-e930-e063-6394a90a7ed02026-05-20Warnings, Adverse reactionsName fallback
brand name: CYCLOBENZAPRINE HYDROCHLORIDE
generic name: CYCLOBENZAPRINE HYDROCHLORIDE
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENuCare Pharmaceuticals, Inc.4fbbc5b6-7aac-34e5-e054-00144ff88e882026-05-19Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINENuCare Pharmaceuticals, Inc.4a2b5f25-a333-15f3-e054-00144ff8d46c2026-05-05Warnings, Adverse reactionsName fallback
brand name: Cyclobenzaprine Hydrochloride

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52817-190Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideTruPharma, LLCANDACurrent
52817-190Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideTruPharma, LLCANDACurrent
52817-191Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideTruPharma, LLCANDACurrent
52817-191Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideTruPharma, LLCANDACurrent
53489-590Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideMutual PharmaceuticalANDACurrent
53489-591Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideMutual PharmaceuticalANDACurrent
53808-0862Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
60760-284Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
68071-4415Cyclobenzaprine hydrochlorideCyclobenzaprine hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent