Application 209063

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RIVASTIGMINERIVASTIGMINEFILM, EXTENDED RELEASE;TRANSDERMAL4.6MG/24HRNoNo
002RIVASTIGMINERIVASTIGMINEFILM, EXTENDED RELEASE;TRANSDERMAL9.5MG/24HRNoNo
003RIVASTIGMINERIVASTIGMINEFILM, EXTENDED RELEASE;TRANSDERMAL13.3MG/24HRNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209063-001RIVASTIGMINERIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26
A209063-002RIVASTIGMINERIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26
A209063-003RIVASTIGMINERIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209063-001AB
A209063-002AB
A209063-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209063-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2019-11-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209063-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209063-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209063-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209063-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209063-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209063-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209063-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209063-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209063-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209063-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209063-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209063-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209063-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209063-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209063-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209063-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209063-001AB18072bd15b7f6…

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
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack8d8823c0-9339-4ec8-8a19-d13974b6614b2025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka7f9328e-b6da-4474-ac93-3cdd4825e1632025-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack5cd5c434-ffd0-4aed-9eba-145c86b115bb2025-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
ndc (product): 63629-8846
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka68d70c9-19f2-47db-bf78-4da04a87a7022025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
ndc (product): 63629-2066
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack6cc286d9-c5d4-4505-83bb-9015e30778512025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
ndc (product): 63629-2064
Rivastigmine Transdermal SystemRIVASTIGMINEBreckenridge Pharmaceutical, Inc.b201fe68-b5e5-4a6f-8cf1-069543f03e762025-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
ndc (product): 51991-899
ndc (product): 51991-898
ndc (product): 51991-897
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack1ebeb8ec-5348-4bb1-ab3d-8346903510942024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack82630f84-fb47-47ab-8ee2-1720a486de022024-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
ndc (product): 63629-2065
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepackc569f760-f311-42ba-909c-a36319622b352024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209063
application number: ANDA209063
ndc (product): 63629-8807

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-897Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-897Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-897Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-898Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-898Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-898Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-899Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-899Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-899Rivastigmine Transdermal SystemRivastigmineBreckenridge Pharmaceutical, Inc.ANDACurrent
63629-2064Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2064Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2064Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2064Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2065Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2065Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2065Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2065Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2065Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2066Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2066Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2066Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-2066Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8807Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8807Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8807Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8807Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8807Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8807Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8846Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8846Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8846Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8846Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
63629-8846Rivastigmine Transdermal SystemRivastigmineBryant Ranch PrepackANDACurrent
72855-100Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-100Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-100Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-101Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-101Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-101Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-102Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-102Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent
72855-102Rivastigmine Transdermal SystemRivastigmineAdhexpharmaANDACurrent