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 2 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.87f362a7-cf66-4166-af51-ac2da473cf6b2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPreferred Pharmaceuticals Inc.939dee35-3987-4ce2-9985-3751ceffa20e2026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.b1c53213-9f84-4389-b6dc-3dc26d9a63642026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.00f323c0-e007-40df-ae7f-e6b3c7ba0aa82026-03-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMProficient Rx LP44f39aa8-a7bc-4e42-977c-31583e6388ae2026-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAvPAKf2662808-01c4-330c-e053-2a95a90aa3352026-02-24Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.a4185456-68f9-47d4-9952-fcdef86989db2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMREMEDYREPACK INC.095a80b0-09f9-4bd1-b377-5212d7c966ba2026-02-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMNorthstar Rx LLC017534e6-49ff-45f3-b88f-2f34cf0cf8fd2026-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
KlonopinCLONAZEPAMH2-Pharma, LLCcfa0d79a-843c-4b88-95a1-e9511d649ca12025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.9ee4e019-6a99-4aac-84b0-9aae597815a72025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.c707caa1-d6fd-4790-9a64-f749bf93ef182025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.1ce88d2c-70f7-427b-8787-4afd9ce6f71c2025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPar Health USA, LLC1aef0069-80ea-483d-ac70-c8d485462c5b2025-10-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.08d0a109-3307-47b5-8ff2-c0ad83e66f082025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.9a74ea97-1c00-4d96-a06f-81c183943dc62025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMPD-Rx Pharmaceuticals, Inc.ca79f244-7e6e-4612-af26-e6e5cefbd3a22025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMSolco Healthcare LLC4acbb7a9-4db5-4497-b8db-9f358b3f6fb42025-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
CLONAZEPAMCLONAZEPAMAlembic Pharmaceuticals Inc.ecb28fcb-f0d1-4558-b460-ecabd0f6009e2025-07-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLONAZEPAM
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMBryant Ranch Prepackdec8b5b2-2490-4880-a8d1-707b579542972025-06-20Boxed 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