Home Applications 081265 Application 081265
Type ANDA
Sponsor CHARTWELL RX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET;ORAL 2MG No No 002 BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET;ORAL 1MG No No 003 BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET;ORAL 0.5MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A081265-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 A081265-002 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 A081265-003 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 99 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 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081265-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1992-01-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081265-003 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA 2023-11-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081265-001 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA 1992-01-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 83 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 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 62135-142 Benztropine Mesylate Benztropine mesylate Chartwell RX, LLC. ANDA Current 62135-142 Benztropine Mesylate Benztropine mesylate Chartwell RX, LLC. ANDA Current 62135-142 Benztropine Mesylate Benztropine mesylate Chartwell RX, LLC. ANDA Current 62135-144 Benztropine Mesylate Benztropine mesylate Chartwell RX, LLC. ANDA Current 62135-144 Benztropine Mesylate Benztropine mesylate Chartwell RX, LLC. ANDA Current 62135-144 Benztropine Mesylate Benztropine mesylate Chartwell RX, LLC. ANDA Current