Application 078654

Type
ANDA
Sponsor
SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.125MGNoNo
002CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.25MGNoNo
003CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL0.5MGNoNo
004CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL1MGNoNo
005CLONAZEPAMCLONAZEPAMTABLET, ORALLY DISINTEGRATING;ORAL2MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078654-001CLONAZEPAMCLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-002CLONAZEPAMCLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-003CLONAZEPAMCLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-004CLONAZEPAMCLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27
A078654-005CLONAZEPAMCLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-09-14 22:38:342026-08A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2784e616aacf4f…
2026-08-18 06:07:402026-07A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORAL2014-08-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-001CLONAZEPAM0.125MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-002CLONAZEPAM0.25MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-003CLONAZEPAM0.5MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-004CLONAZEPAM1MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-005CLONAZEPAM2MGTABLET, ORALLY DISINTEGRATING / ORALAB2014-08-2703ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 175 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078654-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078654-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078654-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078654-005AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078654-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-004AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078654-005AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-004AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078654-005AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-004AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078654-005AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078654-005AB11e350fbaab3a…

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 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.2606ecf9-3d71-4c1c-bfda-d7d98ffc60112026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.9c3b1b37-8bc0-427a-8c7a-14da7bd49a7f2026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.64bb2cdf-f57d-4a41-a5bf-ee77b6e64d062026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMBryant Ranch Prepack19475112-60da-4d53-b330-70afe28ebaf32026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMBryant Ranch Prepackc4b87c17-efcd-4b66-96e7-159a04c808b52026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMBryant Ranch Prepack8bb69bbe-07e1-4123-9b70-fde78d1d0a342026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.874b0395-fecb-446a-966f-6ecbb23f1ff62026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.3aa9c3eb-3a0a-4e8b-af68-4f87d87194dd2026-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAdvagen Pharma Ltd30d674f9-f1b3-4c2d-a8e9-3bc8e476f1ec2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMCoupler LLC54d6e348-4c51-221e-e063-6294a90a9b7d2026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.533a12a8-64fb-494f-a2a4-da1515ef19082026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMUnit Dose Solutions, Inc.54789918-cc0c-7090-e063-6394a90aeba72026-06-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.1fb0807c-dccd-47a5-ada4-91418c4f47f52026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.f613573a-3e8b-4abf-af69-0268f3d6f4812026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMMajor Pharmaceuticals34366dd2-432c-4fa9-8fab-832cca781b842026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
clonazepamCLONAZEPAMAdvagen Pharma Ltd19fc756c-72fe-4504-beaa-4fa2235af18c2026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMCoupler LLC511216c7-6878-f90a-e063-6394a90aaac82026-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMCardinal Health 107, LLC5ad315f2-fa09-4956-b931-f9966fb73e4e2026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.2fe0d214-9c4d-4a0c-9024-c2076c092c1a2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.f803fefc-69ff-4963-950b-48c13998bc2c2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM

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 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
57664-783ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-783ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-783ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-783ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-783ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-783ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-784ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-784ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-784ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-784ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-784ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-784ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-785ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-785ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-785ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-785ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-785ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-785ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-786ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-786ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-786ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-786ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-786ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-786ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-787ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-787ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-787ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-787ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-787ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent
57664-787ClonazepamClonazepamSun Pharmaceutical Industries, Inc.ANDACurrent