Application 074979

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONAZEPAMCLONAZEPAMTABLET;ORAL0.5MGNoNo
002CLONAZEPAMCLONAZEPAMTABLET;ORAL1MGNoNo
003CLONAZEPAMCLONAZEPAMTABLET;ORAL2MGNoNo

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

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
A074979-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB1997-08-29
A074979-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB1997-08-29
A074979-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB1997-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074979-001AB
A074979-002AB
A074979-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-2984e616aacf4f…
2026-09-14 22:38:342026-08A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-2984e616aacf4f…
2026-09-14 22:38:342026-08A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-2984e616aacf4f…
2026-08-18 06:07:402026-07A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-29caaa826d4ba7…
2026-08-18 06:07:402026-07A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074979-002CLONAZEPAM1MGTABLET / ORALAB1997-08-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074979-003CLONAZEPAM2MGTABLET / ORALAB1997-08-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074979-001CLONAZEPAM0.5MGTABLET / ORALAB1997-08-29301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074979-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A074979-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A074979-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A074979-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074979-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074979-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074979-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074979-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074979-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074979-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074979-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074979-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074979-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074979-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074979-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074979-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074979-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074979-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074979-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074979-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074979-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074979-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074979-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074979-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074979-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074979-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074979-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074979-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074979-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074979-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074979-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074979-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074979-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074979-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074979-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074979-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074979-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074979-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074979-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074979-001AB1301d65b070ca…

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 3 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMA-S Medication Solutions28675dd6-b952-4e71-b0a3-b701ad6b63442025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMSt Marys Medical Park Pharmacy31a7ed52-48a6-1c87-e054-00144ff88e882025-05-22Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAmerican Health Packagingc13297e2-ae3e-4198-b7c8-55fd672436aa2025-03-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMCoupler LLC2e970dc2-cd78-bcdf-e063-6294a90ad3e02025-02-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMCoupler LLC2cdb55a7-54e4-17b6-e063-6294a90ac8272025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMDirect_Rxfc75869c-cd6b-44a3-e053-6294a90a699e2025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
CLONAZEPAMCLONAZEPAMDIRECT RXa821f647-be5f-274c-e053-2a95a90a23ce2025-01-17Warnings, Adverse reactionsName fallback
brand name: CLONAZEPAM
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAdvanced Rx of Tennessee, LLC04db8e8c-38f9-0c4a-e063-6394a90a93f02024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCb9309a1a-a794-2f62-e053-2a95a90a7c342024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAdvanced Rx Pharmacy of Tennessee, LLCbe383e56-d71f-7699-e053-2995a90a50c12024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC263f99eb-9744-5601-e063-6394a90a47b12024-11-14Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC8891c5aa-f42a-4206-92b9-f0ed0631dfcb2024-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC214e760b-c909-bd93-e063-6294a90ae74a2024-10-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.555061d4-276a-4716-e054-00144ff88e882024-10-16Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC66bf60fa-61ac-47a7-a081-36077af9007e2024-10-14Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC7b0d716c-8f51-47a7-8bf2-07c6f9732a052024-09-29Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC20b3125e-4489-3c53-e063-6294a90a65392024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMBryant Ranch Prepackb12661a6-2141-42a9-bcb0-c0aef81395ce2024-08-23Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMBryant Ranch Prepackb83009c2-26ed-45fa-819e-164cdac264e62024-08-23Warnings, Adverse reactionsName fallback
brand name: Clonazepam
generic name: CLONAZEPAM
ClonazepamCLONAZEPAMBryant Ranch Prepack96518266-8f75-4301-b8fd-d2995a7f486d2024-08-06Warnings, 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 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0063ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0063ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0064ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0064ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0065ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0185-0065ClonazepamClonazepamEon Labs, Inc.ANDACurrent
0781-5567ClonazepamClonazepamSandoz IncANDACurrent
0781-5567ClonazepamClonazepamSandoz IncANDACurrent
0781-5569ClonazepamClonazepamSandoz IncANDACurrent
0781-5569ClonazepamClonazepamSandoz IncANDACurrent
0781-8018ClonazepamClonazepamSandoz IncANDACurrent
0781-8018ClonazepamClonazepamSandoz IncANDACurrent
0904-6101ClonazepamClonazepamMajor PharmaceuticalsANDACurrent
0904-6102ClonazepamClonazepamMajor PharmaceuticalsANDACurrent
0904-6103ClonazepamClonazepamMajor PharmaceuticalsANDACurrent
16714-469ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-469ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-470ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-470ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-471ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-471ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-750ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-750ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-751ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-751ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-752ClonazepamClonazepamNorthstar RxLLCANDACurrent
16714-752ClonazepamClonazepamNorthstar RxLLCANDACurrent
50090-1565ClonazepamClonazepamA-S Medication SolutionsANDACurrent
50090-2878ClonazepamClonazepamA-S Medication SolutionsANDACurrent
50090-2878ClonazepamClonazepamA-S Medication SolutionsANDACurrent
50090-3467ClonazepamClonazepamA-S Medication SolutionsANDACurrent
53217-189ClonazepamClonazepamAidarex Pharmaceuticals LLCANDACurrent
53217-247ClonazepamClonazepamAidarex Pharmaceuticals LLCANDACurrent
53217-326ClonazepamClonazepamAidarex Pharmaceuticals LLCANDACurrent
70518-0154ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-0259ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-0259ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1069ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1069ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1199ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-1199ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
71335-0001ClonazepamClonazepamBryant Ranch PrepackANDACurrent
71335-0001ClonazepamClonazepamBryant Ranch PrepackANDACurrent
71335-1060ClonazepamClonazepamBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22398ORIG2011-03-10