Application 204403

Type
ANDA
Sponsor
ALVOGEN

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 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
A204403-001RIVASTIGMINERIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-03
A204403-002RIVASTIGMINERIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-03
A204403-003RIVASTIGMINERIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-08-31

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 06:07:402026-07A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-03caaa826d4ba7…
2026-08-18 06:07:402026-07A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-08-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-08-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-08-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-09-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2015-08-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204403-002RIVASTIGMINE9.5MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204403-003RIVASTIGMINE13.3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-08-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204403-001RIVASTIGMINE4.6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB2015-09-031e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204403-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204403-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204403-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204403-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204403-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204403-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204403-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204403-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204403-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204403-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204403-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204403-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204403-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204403-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204403-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204403-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204403-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204403-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204403-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204403-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204403-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204403-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204403-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204403-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204403-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204403-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204403-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204403-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204403-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204403-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204403-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204403-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204403-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204403-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204403-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204403-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204403-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204403-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204403-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204403-001AB14b0b4de00fa7…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RivastigmineRIVASTIGMINEZydus Lifesciences Limited966d59ea-5cea-4fef-8b96-e0efe885caf42025-11-17Name fallback
brand name: Rivastigmine
generic name: RIVASTIGMINE
RivastigmineRIVASTIGMINENorthstar Rx LLC.8b809739-8381-4cc1-ab4a-5b17ab902a3d2025-11-14Warnings, Adverse reactionsName fallback
brand name: Rivastigmine
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack8d8823c0-9339-4ec8-8a19-d13974b6614b2025-04-01Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka7f9328e-b6da-4474-ac93-3cdd4825e1632025-04-01Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack5cd5c434-ffd0-4aed-9eba-145c86b115bb2025-03-27Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepacka68d70c9-19f2-47db-bf78-4da04a87a7022025-03-20Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack6cc286d9-c5d4-4505-83bb-9015e30778512025-03-19Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBreckenridge Pharmaceutical, Inc.b201fe68-b5e5-4a6f-8cf1-069543f03e762025-01-15Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack1ebeb8ec-5348-4bb1-ab3d-8346903510942024-12-24Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
RivastigmineRIVASTIGMINEMylan Pharmaceuticals Inc.4ab335d1-19ee-4cd9-9776-8086645d19e42024-09-21Warnings, Adverse reactionsName fallback
brand name: Rivastigmine
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepack82630f84-fb47-47ab-8ee2-1720a486de022024-08-19Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
RivastigmineRIVASTIGMINEAmneal Pharmaceuticals LLC8b671fc9-8cb0-4406-a9ee-7c95086d62002024-07-02Warnings, Adverse reactionsName fallback
brand name: Rivastigmine
generic name: RIVASTIGMINE
Rivastigmine Transdermal SystemRIVASTIGMINEBryant Ranch Prepackc569f760-f311-42ba-909c-a36319622b352024-05-30Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
RivastigmineRIVASTIGMINEZydus Pharmaceuticals USA Inc.64dad603-2389-456b-8c18-d1d40b7e74192024-05-27Warnings, Adverse reactionsName fallback
brand name: Rivastigmine
generic name: RIVASTIGMINE
RivastigmineRIVASTIGMINESandoz Inc92a58ebb-748d-49f4-bf11-ecbcf54241522024-05-08Warnings, Adverse reactionsName fallback
brand name: Rivastigmine
generic name: RIVASTIGMINE
ExelonRIVASTIGMINENovartis Pharmaceuticals Corporation07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e02024-05-08Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE
ExelonRIVASTIGMINESandoz Incb6ed6d15-116d-4596-92ce-3414574d7ba02024-05-08Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-304Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-305Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent
47781-405Rivastigmine Transdermal SystemRivastigmine Transdermal SystemAlvogen Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58718ORIG2019-05-15
32549ORIG2015-09-08
32550ORIG2015-07-23