Application 077563

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL7.5MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077563-001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19
A077563-002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19
A077563-003CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077563-001AB
A077563-002AB
A077563-003AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-002CYCLOBENZAPRINE HYDROCHLORIDE10MGTABLET / ORALAB2006-04-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-003CYCLOBENZAPRINE HYDROCHLORIDE7.5MGTABLET / ORALAB2017-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077563-001CYCLOBENZAPRINE HYDROCHLORIDE5MGTABLET / ORALAB2006-04-198072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077563-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077563-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077563-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077563-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077563-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077563-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077563-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077563-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077563-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077563-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077563-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077563-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077563-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077563-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077563-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077563-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077563-001AB18072bd15b7f6…

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.84be93c5-1526-465e-ab0b-c6d10ba1521d2026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLDirect_Rx55683c5c-0f86-9a26-e063-6294a90a8e8c2026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDECoupler LLC47d22c6d-49fb-f97c-e063-6294a90a6ba12026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEDoc Rx4c054230-1978-44d2-9467-ed19946191132025-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC3bddfe25-00ba-747f-e063-6394a90a9ce62025-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDESOLA Pharmaceuticals, LLCdb930d05-3f92-41f1-888c-301b2c4565e62025-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAvKAREa264ab9f-cc12-325f-e053-2a95a90a53d92025-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
ndc (product): 42291-154
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC34f4e63a-1259-0226-e063-6294a90a9fc42025-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepack3f1b9c8a-8f75-4b84-af0c-739815937fd72025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEBryant Ranch Prepackdcef9b63-f998-4852-920d-c356623cea6a2025-03-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
ndc (product): 63629-2424
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEJubilant Cadista Pharmaceuticals Inc.592871f6-0eb2-4624-9e10-bd8bf767c0022025-02-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
ndc (product): 59746-735
ndc (product): 59746-211
ndc (product): 59746-177
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLAdvanced Rx of Tennessee, LLCafca2a49-6424-7b6a-e053-2a95a90ad41e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077563
application number: ANDA077563
ndc (product): 80425-0017

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0057cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0179-0189cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
21695-036Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRebel DistributorsANDACurrent
42291-154Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAvKAREANDACurrent
42291-154Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAvKAREANDACurrent
50090-4024Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4024Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4026Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4105Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4105Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4205Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5326Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5326Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideA-S Medication SolutionsANDACurrent
50436-9804Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideUnit Dose ServicesANDACurrent
53808-1039cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideState of Florida DOH Central PharmacyANDACurrent
59746-177Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-211Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-735Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
63629-2424Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2424Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
67046-119cyclobenzaprine hydrochloridecyclobenzaprine hydrochlorideContract Pharmacy Services-PAANDACurrent
67296-1763Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
67296-1763Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRedPharm Drug, Inc.ANDACurrent
71610-379Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
80425-0017FlexerilCyclobenzaprine HCl 5mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0017Cyclobenzaprine HCLCyclobenzaprine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0017Cyclobenzaprine HCLCyclobenzaprine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent