FDA.reportPublic FDA data

Application 021025

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EXELONRIVASTIGMINE TARTRATESOLUTION;ORALEQ 2MG BASE/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021025-001EXELONRIVASTIGMINE TARTRATEEQ 2MG BASE/MLSOLUTION / ORALRLD2000-04-21

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021025-001EXELONEQ 2MG BASE/MLSOLUTION / ORAL2000-04-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021025-001EXELONEQ 2MG BASE/MLSOLUTION / ORAL2000-04-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021025-001EXELONEQ 2MG BASE/MLSOLUTION / ORAL2000-04-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021025-001EXELONEQ 2MG BASE/MLSOLUTION / ORALRLD2000-04-21a50c72e98297…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rivastigmine TartrateRIVASTIGMINE TARTRATEAmerican Health Packaging52781229-ee82-43f9-a113-4419a611978d2025-11-11Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATEMajor Pharmaceuticals39aadc39-0f4f-44f7-88de-83a0ea2ac3322025-03-03Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATEAurobindo Pharma Limitedc246a0e5-1e77-41ee-a7b3-384f21f2f2e02024-06-19Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
ExelonRIVASTIGMINENovartis Pharmaceuticals Corporation07c12e14-bbd5-4ec8-84e4-fbe7b5ba10e02024-05-08Warnings, Adverse reactionsName fallback
brand name: Exelon
ExelonRIVASTIGMINESandoz Incb6ed6d15-116d-4596-92ce-3414574d7ba02024-05-08Warnings, Adverse reactionsName fallback
brand name: Exelon
Rivastigmine TartrateRIVASTIGMINE TARTRATEChartwell RX, LLC2bb5e0d6-f677-4021-9888-3ff90979ef7d2023-10-06Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATEAlembic Pharmaceuticals Limited33e6a772-382d-45f5-9d45-966c077593672023-01-16Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATECadila Pharmaceuticals Limitede7e641fe-39bd-4681-a430-6dedeb6d6af52022-12-29Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATEModavar Pharmaceuticals LLC209f3b02-0acf-46e9-b355-91c918a20eb32022-12-28Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
RIVASTIGMINE TARTRATERIVASTIGMINE TARTRATEMacleods Pharmaceuticals Limited4364f6ef-a8da-4805-be0d-aabbe8ca2d212022-08-24Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATEAlembic Pharmaceuticals Inc.0044f1d7-613c-4611-8481-13032c8cb3902022-03-21Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATESun Pharmaceutical Industries, Inc.bac9ca81-db70-41aa-82af-6c5bb84968462019-01-31Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE
Rivastigmine TartrateRIVASTIGMINE TARTRATEDr. Reddy's Laboratories Limited0e20124c-725a-0145-996c-2ff9087031622019-01-23Warnings, Adverse reactionsName fallback
generic name: RIVASTIGMINE TARTRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56929SUPPL2018-12-21
56794SUPPL2018-12-19
45807SUPPL2016-11-04
45800SUPPL2016-11-03
35922SUPPL2015-02-05
4083SUPPL2015-02-05
35921SUPPL2013-10-08
35920SUPPL2013-10-08
14194SUPPL2013-10-08
26523SUPPL2013-10-04
4082SUPPL2013-10-04
4081SUPPL2013-10-04
21358SUPPL2007-06-18
26522SUPPL2006-07-03
35919SUPPL2006-06-28
21359SUPPL2006-06-27
4080SUPPL2004-09-24
26521SUPPL2004-05-07
41886ORIG2000-04-21
35918ORIG2000-04-21
4079ORIG2000-04-21