Application 077856

Type
ANDA
Sponsor
PRINSTON INC

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
A077856-001CLONAZEPAMCLONAZEPAM0.5MGTABLET / ORALAB2006-06-28
A077856-002CLONAZEPAMCLONAZEPAM1MGTABLET / ORALAB2006-06-28
A077856-003CLONAZEPAMCLONAZEPAM2MGTABLET / ORALAB2006-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077856-001AB
A077856-002AB
A077856-003AB

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 22:38:342026-08A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-09-14 22:38:342026-08A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2884e616aacf4f…
2026-08-18 06:07:402026-07A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-002CLONAZEPAM1MGTABLET / ORALAB2006-06-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-003CLONAZEPAM2MGTABLET / ORALAB2006-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-001CLONAZEPAM0.5MGTABLET / ORALAB2006-06-28301d65b070ca…

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 22:38:342026-08A077856-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077856-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077856-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077856-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077856-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077856-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077856-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077856-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077856-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077856-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077856-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077856-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077856-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077856-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077856-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077856-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077856-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077856-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077856-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077856-001AB1301d65b070ca…

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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClonazepamCLONAZEPAMBryant Ranch Prepackf06dc5fc-94e0-496e-bdf0-11f2b6ffc7862024-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 63629-1207
ClonazepamCLONAZEPAMBryant Ranch Prepack254a03c9-070c-40e6-83ac-524c1aec3b6b2024-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 63629-1116
ClonazepamCLONAZEPAMNuCare Pharmaceuticals,Inc.19b1fe7b-8f7b-03b7-e063-6394a90a9ba52024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC154806ed-91af-fc7f-e063-6294a90ae0f42024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack5ec3df57-1137-4402-84e6-28dd762864272024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 63629-8988
ClonazepamCLONAZEPAMAphena Pharma Solutions - Tennessee, LLC2cb46dc0-a03e-42d7-ba67-22319598389f2024-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackbaa86bf1-75f3-44da-b67f-b6e4b5303f1e2024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackcd364371-d2af-4cb4-a5df-3d3149580e162024-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepackd732be07-6eb7-48f2-b6cd-28baad46aca52024-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 63629-1203
ClonazepamCLONAZEPAMBryant Ranch Prepack5f3a2f64-57ed-475c-9d8c-b2094bf1d79e2023-10-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 71335-1856
ClonazepamCLONAZEPAMBryant Ranch Prepack5ae98718-9da5-4edc-8efb-67b2125775482023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 63629-1205
ClonazepamCLONAZEPAMBryant Ranch Prepackcc14bb7b-d0c8-4f41-bcd9-a0c860b45a432023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 63629-1206
ClonazepamCLONAZEPAMProficient Rx LP645fb912-479c-46de-b99c-4ea341bfd9ba2023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ClonazepamCLONAZEPAMBryant Ranch Prepack6960e994-e9ea-4a4a-b674-7e6124d8b3812023-05-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 63629-1202
ClonazepamCLONAZEPAMProficient Rx LP63286201-4b79-45b8-8f48-7e21dadc14082021-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077856
application number: ANDA077856
ndc (product): 71205-529

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 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-2948ClonazepamclonazepamQualitest PharmaceuticalsANDACurrent
0904-7227ClonazepamclonazepamMajor PharmaceuticalsANDACurrent
0904-7728ClonazepamclonazepamMajor PharmaceuticalsANDACurrent
33261-029ClonazepamclonazepamAidarex Pharmaceuticals LLCANDACurrent
33261-340ClonazepamclonazepamAidarex Pharmaceuticals LLCANDACurrent
33261-628ClonazepamclonazepamAidarex Pharmaceuticals LLCANDACurrent
43353-277ClonazepamclonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-799ClonazepamclonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
43547-406ClonazepamclonazepamSolco Healthcare LLCANDACurrent
43547-406ClonazepamclonazepamSolco Healthcare LLCANDACurrent
43547-407ClonazepamclonazepamSolco Healthcare LLCANDACurrent
43547-407ClonazepamclonazepamSolco Healthcare LLCANDACurrent
43547-408ClonazepamclonazepamSolco Healthcare LLCANDACurrent
43547-408ClonazepamclonazepamSolco Healthcare LLCANDACurrent
50436-2948ClonazepamclonazepamUnit Dose ServicesANDACurrent
63629-1116ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1116ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1201ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1201ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1202ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1202ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1203ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1203ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1204ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1204ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1205ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1205ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1206ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1206ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1207ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-1207ClonazepamclonazepamBryant Ranch PrepackANDACurrent
63629-8988ClonazepamclonazepamBryant Ranch PrepackANDACurrent
66336-588ClonazepamclonazepamDispensing Solutions, Inc.ANDACurrent
66336-819ClonazepamclonazepamDispensing Solutions, Inc.ANDACurrent
66336-980ClonazepamclonazepamDispensing Solutions, Inc.ANDACurrent
67046-916ClonazepamclonazepamContract Pharmacy Services-PAANDACurrent
67544-697ClonazepamclonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-9495ClonazepamclonazepamPreferred Pharmaceuticals, Inc.ANDACurrent
70518-1353ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-1353ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-1353ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-1353ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-1353ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-1353ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-1353ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2392ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2392ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2392ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2467ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2467ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2467ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2467ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2467ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2485ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2485ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2485ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2485ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2485ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2533ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2533ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2533ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
70518-2533ClonazepamclonazepamREMEDYREPACK INC.ANDACurrent
71205-529ClonazepamclonazepamProficient Rx LPANDACurrent
71335-1810ClonazepamclonazepamBryant Ranch PrepackANDACurrent
71335-1843ClonazepamclonazepamBryant Ranch PrepackANDACurrent
71335-1856ClonazepamclonazepamBryant Ranch PrepackANDACurrent
71610-363ClonazepamclonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-368ClonazepamclonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-368ClonazepamclonazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-081CLONAZEPAMCLONAZEPAMDIRECT RXANDACurrent
72189-081CLONAZEPAMCLONAZEPAMDIRECT RXANDACurrent