Home Applications 204713 Application 204713
Type ANDA
Sponsor ASPEN GLOBAL INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET;ORAL 0.5MG No Yes 002 BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET;ORAL 1MG No Yes 003 BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET;ORAL 2MG No Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204713-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 A204713-002 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 A204713-003 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204713-002 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA RS 2015-04-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204713-003 BENZTROPINE MESYLATE 2MG TABLET / ORAL AA RS 2015-04-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204713-001 BENZTROPINE MESYLATE 0.5MG TABLET / ORAL AA RS 2015-04-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 72 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0603-2437 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2437 Benztropine Mesylate benztropine mesylate Par Pharmaceutical ANDA Current 0603-2437 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2437 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2438 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2438 Benztropine Mesylate benztropine mesylate Par Pharmaceutical ANDA Current 0603-2438 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2438 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2439 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2439 Benztropine Mesylate benztropine mesylate Par Pharmaceutical ANDA Current 0603-2439 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0603-2439 Benztropine Mesylate benztropine mesylate Par Pharmaceutical, Inc. ANDA Current 0615-8210 Benztropine Mesylate benztropine mesylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8210 Benztropine Mesylate benztropine mesylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8210 Benztropine Mesylate benztropine mesylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8211 Benztropine Mesylate benztropine mesylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8211 Benztropine Mesylate benztropine mesylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8211 Benztropine Mesylate benztropine mesylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8352 benztropine mesylate benztropine mesylate NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0904-6788 Benztropine Mesylate benztropine mesylate Major Pharmaceuticals ANDA Current 0904-6788 Benztropine Mesylate benztropine mesylate Major Pharmaceuticals ANDA Current 0904-6789 Benztropine Mesylate benztropine mesylate Major Pharmaceuticals ANDA Current 0904-6789 Benztropine Mesylate benztropine mesylate Major Pharmaceuticals ANDA Current 0904-6790 Benztropine Mesylate benztropine mesylate Major Pharmaceuticals ANDA Current 0904-6790 Benztropine Mesylate benztropine mesylate Major Pharmaceuticals ANDA Current 0904-6790 Benztropine Mesylate benztropine mesylate Major Pharmaceuticals ANDA Current 43353-580 Benztropine Mesylate benztropine mesylate Aphena Pharma Solutions - Tennnessee, LLC ANDA Current 43353-580 Benztropine Mesylate benztropine mesylate Aphena Pharma Solutions - Tennnessee, LLC ANDA Current 43353-707 Benztropine Mesylate benztropine mesylate Aphena Pharma Solutions - Tennnessee, LLC ANDA Current 50090-3116 Benztropine Mesylate benztropine mesylate A-S Medication Solutions ANDA Current 50090-3116 Benztropine Mesylate benztropine mesylate A-S Medication Solutions ANDA Current 50090-3382 Benztropine Mesylate benztropine mesylate A-S Medication Solutions ANDA Current 50090-4082 Benztropine Mesylate benztropine mesylate A-S Medication Solutions ANDA Current 55154-8095 Benztropine Mesylate benztropine mesylate Cardinal Health ANDA Current 55154-8095 Benztropine Mesylate benztropine mesylate Cardinal Health 107, LLC ANDA Current 60687-356 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-356 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-356 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-368 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-368 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-368 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-379 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-379 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 60687-379 Benztropine Mesylate benztropine mesylate American Health Packaging ANDA Current 63629-2132 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 63629-2132 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 63629-2133 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 63629-2133 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 63629-2134 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 63629-2134 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 63629-2135 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 63629-2135 Benztropine Mesylate benztropine mesylate Bryant Ranch Prepack ANDA Current 70518-0881 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-0881 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-0881 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-0881 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1447 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1447 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1447 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1447 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1447 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1447 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1691 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1691 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1691 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1691 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1709 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1709 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1709 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1709 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1709 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current 70518-1709 Benztropine Mesylate benztropine mesylate REMEDYREPACK INC. ANDA Current