Application 074569

Type
ANDA
Sponsor
TEVA

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 42.

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
A074569-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB1996-09-10
A074569-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB1996-09-10
A074569-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB1996-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074569-001AB
A074569-002AB
A074569-003AB

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-002CLONAZEPAM1MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-003CLONAZEPAM2MGTABLET / ORALAB1996-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074569-001CLONAZEPAM0.5MGTABLET / ORALAB1996-09-101e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074569-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074569-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074569-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074569-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074569-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074569-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074569-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074569-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074569-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074569-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074569-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074569-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074569-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074569-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074569-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074569-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074569-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074569-001AB11e350fbaab3a…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMREMEDYREPACK INC.64bb2cdf-f57d-4a41-a5bf-ee77b6e64d062026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMCoupler LLC54d6e348-4c51-221e-e063-6294a90a9b7d2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMREMEDYREPACK INC.b1c53213-9f84-4389-b6dc-3dc26d9a63642026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ndc (product): 70518-2507
ClonazepamCLONAZEPAMA-S Medication Solutionsb3c9d04a-431f-4cec-a809-847dfb8de7362024-05-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMClinical Solutions Wholesale, LLC429a15d1-1675-42cc-97f1-c49b037474162024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ndc (product): 58118-0832
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC73125f86-ce24-44c0-a2b1-a5d12a607a942023-11-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC6be64dc3-3748-477c-8800-2c2175309c732023-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ndc (product): 67544-529
ClonazepamCLONAZEPAMTeva Pharmaceuticals USA, Inc.8069b1a0-7c06-4252-b44e-e2eef065d9b82023-04-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ndc (product): 0093-3212
ndc (product): 0093-0832
ndc (product): 0093-3213
ClonazepamCLONAZEPAMProficient Rx LP56175c25-3fde-43ea-89bf-22dcf3278b6b2022-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074569
application number: ANDA074569
ndc (product): 63187-226

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 97 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0832ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0832ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0832ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0832ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0832ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0832ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0832ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0833ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0834ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3212ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3212ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3212ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3212ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3212ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3212ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3212ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3213ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3213ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3213ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3213ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3213ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3213ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-3213ClonazepamClonazepamTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-8001ClonazepamClonazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8001ClonazepamClonazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8002ClonazepamClonazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8002ClonazepamClonazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8048ClonazepamClonazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8048ClonazepamClonazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-260ClonazepamClonazepamRebel DistributorsANDACurrent
21695-261ClonazepamClonazepamRebel DistributorsANDACurrent
21695-262ClonazepamClonazepamRebel DistributorsANDACurrent
35356-722ClonazepamClonazepamLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-722ClonazepamClonazepamQuality Care Products, LLCANDACurrent
35356-722ClonazepamClonazepamQuality Care Products, LLCANDACurrent
50090-4842ClonazepamClonazepamA-S Medication SolutionsANDACurrent
50090-4842ClonazepamClonazepamA-S Medication SolutionsANDACurrent
51407-524ClonazepamClonazepamGolden State Medical Supply Inc.ANDACurrent
51407-524ClonazepamClonazepamGolden State Medical Supply Inc.ANDACurrent
51407-524ClonazepamClonazepamGolden State Medical Supply, Inc.ANDACurrent
51407-524ClonazepamClonazepamGolden State Medical Supply, Inc.ANDACurrent
51407-524ClonazepamClonazepamGolden State Medical Supply, Inc.ANDACurrent
51407-525ClonazepamClonazepamGolden State Medical Supply Inc.ANDACurrent
51407-526ClonazepamClonazepamGolden State Medical Supply Inc.ANDACurrent
51655-865ClonazepamClonazepamNorthwind PharmaceuticalsANDACurrent
53002-1306ClonazepamClonazepamRPK Pharmaceuticals, Inc.ANDACurrent
53002-1451ClonazepamClonazepamRPK Pharmaceuticals, Inc.ANDACurrent
55700-564ClonazepamClonazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-564ClonazepamClonazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-564ClonazepamClonazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-564ClonazepamClonazepamLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-830ClonazepamClonazepamQuality Care Products, LLCANDACurrent
58118-0382ClonazepamClonazepamClinical Solutions Wholesale, LLCANDACurrent
58118-0832ClonazepamClonazepamClinical Solutions Wholesale, LLCANDACurrent
58118-0832ClonazepamClonazepamClinical Solutions Wholesale, LLCANDACurrent
60687-544ClonazepamClonazepamAmerican Health PackagingANDACurrent
60687-544ClonazepamClonazepamAmerican Health PackagingANDACurrent
60687-544ClonazepamClonazepamAmerican Health PackagingANDACurrent
60687-555ClonazepamClonazepamAmerican Health PackagingANDACurrent
60687-555ClonazepamClonazepamAmerican Health PackagingANDACurrent
60687-555ClonazepamClonazepamAmerican Health PackagingANDACurrent
61919-059CLONAZEPAMCLONAZEPAMDirect RxANDACurrent
63187-226ClonazepamClonazepamProficient Rx LPANDACurrent
63187-226ClonazepamClonazepamProficient Rx LPANDACurrent
63187-226ClonazepamClonazepamProficient Rx LPANDACurrent
63187-226ClonazepamClonazepamProficient Rx LPANDACurrent
63187-273ClonazepamClonazepamProficient Rx LPANDACurrent
67046-914ClonazepamClonazepamContract Pharmacy Services-PAANDACurrent
67046-920ClonazepamClonazepamContract Pharmacy Services-PAANDACurrent
67544-256ClonazepamClonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-288ClonazepamClonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-529ClonazepamClonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-9378ClonazepamClonazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9378ClonazepamClonazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9379ClonazepamClonazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9379ClonazepamClonazepamPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2507ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-2507ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-2507ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent
70518-2507ClonazepamClonazepamREMEDYREPACK INC.ANDACurrent