Application 200292

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET;ORAL5MGNoNo
002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200292-001DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31
A200292-002DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A200292-001AB
A200292-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31caaa826d4ba7…
2026-08-18 06:07:402026-07A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200292-001DONEPEZIL HYDROCHLORIDE5MGTABLET / ORALAB2011-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200292-002DONEPEZIL HYDROCHLORIDE10MGTABLET / ORALAB2011-05-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A200292-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A200292-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200292-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200292-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200292-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200292-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200292-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200292-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200292-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200292-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200292-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200292-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200292-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200292-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200292-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200292-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200292-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200292-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200292-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200292-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200292-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200292-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200292-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200292-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200292-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200292-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200292-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200292-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200292-002AB1bb7c543d1eb4…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEREMEDYREPACK INC.41c095b6-acd9-4627-a813-bbca7ecafee52026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 70518-1666
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC48178cb4-4fee-47c0-88e9-a4f017f1f4482025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDESolco Healthcare US, LLC042a59ea-131a-4806-b0f4-2f791d4414e22025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 43547-276
ndc (product): 43547-275
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_Rx93dddf28-094b-dd8c-e053-2995a90a63e92025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 72189-031
DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirectRxcb1b3ed1-6e68-08e2-e053-2995a90a68c42025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 72189-265
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEBryant Ranch Prepackc26d9bf3-e148-48bb-8f4f-e8c73804b3112023-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 71335-0900
donepezil hydrochlorideDONEPEZIL HYDROCHLORIDEA-S Medication Solutions5d46ef3c-0dee-4389-a2d5-997ea83428172023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200292
application number: ANDA200292
ndc (product): 50090-3537

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-275donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
43547-276donepezil hydrochloridedonepezil hydrochlorideSolco Healthcare US, LLCANDACurrent
50090-1287donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-3537donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-3537donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
50090-3537donepezil hydrochloridedonepezil hydrochlorideA-S Medication SolutionsANDACurrent
67046-144donepezil hydrochloridedonepezil hydrochlorideContract Pharmacy Services-PAANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1523donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1572donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, IANDACurrent
68071-1572donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1572donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1700donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,InANDACurrent
68071-1700donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1700donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3396donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3396donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3396donepezil hydrochloridedonepezil hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7732donepezil hydrochloridedonepezil hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7732donepezil hydrochloridedonepezil hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7732donepezil hydrochloridedonepezil hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0452donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1666donepezil hydrochloridedonepezil hydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0900donepezil hydrochloridedonepezil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0900donepezil hydrochloridedonepezil hydrochlorideBryant Ranch PrepackANDACurrent
71335-0900donepezil hydrochloridedonepezil hydrochlorideBryant Ranch PrepackANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-031DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirect_RxANDACurrent
72189-265DONEPEZIL HYDROCHLORIDEDONEPEZIL HYDROCHLORIDEDirectRxANDACurrent