Home Applications 207797 Application 207797
Type ANDA
Sponsor CHARTWELL RX 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 A207797-001 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 A207797-002 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 A207797-003 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 A207797-004 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28
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 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207797-001 RIVASTIGMINE TARTRATE EQ 1.5MG BASE CAPSULE / ORAL AB 2017-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207797-002 RIVASTIGMINE TARTRATE EQ 3MG BASE CAPSULE / ORAL AB 2017-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207797-003 RIVASTIGMINE TARTRATE EQ 4.5MG BASE CAPSULE / ORAL AB 2017-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207797-004 RIVASTIGMINE TARTRATE EQ 6MG BASE CAPSULE / ORAL AB 2017-09-28 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 27241-090 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE Ajanta Pharma Limited ANDA Current 27241-091 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE Ajanta Pharma Limited ANDA Current 27241-092 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE Ajanta Pharma Limited ANDA Current 27241-093 RIVASTIGMINE TARTRATE RIVASTIGMINE TARTRATE Ajanta Pharma Limited ANDA Current