Home Applications 090879 Application 090879
Type ANDA
Sponsor ORCHID HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 1.5MG BASE No No 002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 3MG BASE No No 003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 4.5MG BASE No No 004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE CAPSULE;ORAL EQ 6MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090879-001 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 A090879-002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 A090879-003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 A090879-004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090879-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2015-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090879-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2015-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090879-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2015-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090879-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2015-06-10 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
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 · 12 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rivastigmine Tartrate RIVASTIGMINE TARTRATE American Health Packaging 52781229-ee82-43f9-a113-4419a611978d 2025-11-11 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Major Pharmaceuticals 39aadc39-0f4f-44f7-88de-83a0ea2ac332 2025-03-03 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Aurobindo Pharma Limited c246a0e5-1e77-41ee-a7b3-384f21f2f2e0 2024-06-19 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Chartwell RX, LLC 2bb5e0d6-f677-4021-9888-3ff90979ef7d 2023-10-06 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Alembic Pharmaceuticals Limited 33e6a772-382d-45f5-9d45-966c07759367 2023-01-16 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Cadila Pharmaceuticals Limited e7e641fe-39bd-4681-a430-6dedeb6d6af5 2022-12-29 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Modavar Pharmaceuticals LLC 209f3b02-0acf-46e9-b355-91c918a20eb3 2022-12-28 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE Macleods Pharmaceuticals Limited 4364f6ef-a8da-4805-be0d-aabbe8ca2d21 2022-08-24 Warnings, Adverse reactions Name fallback brand name: RIVASTIGMINE TARTRATE generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Alembic Pharmaceuticals Inc. 0044f1d7-613c-4611-8481-13032c8cb390 2022-03-21 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE Nivagen Pharmaceuticals, Inc. 83bd2ff6-1d8b-4cac-a37b-fd01dc3f34a1 2022-02-16 Warnings, Adverse reactions Name fallback brand name: RIVASTIGMINE TARTRATE generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Sun Pharmaceutical Industries, Inc. bac9ca81-db70-41aa-82af-6c5bb8496846 2019-01-31 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE Rivastigmine Tartrate RIVASTIGMINE TARTRATE Dr. Reddy's Laboratories Limited 0e20124c-725a-0145-996c-2ff908703162 2019-01-23 Warnings, Adverse reactions Name fallback brand name: Rivastigmine Tartrate generic name: RIVASTIGMINE TARTRATE