Home Applications 072265 Application 072265
Type ANDA
Sponsor EPIC PHARMA LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE TABLET;ORAL 1MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072265-001 BENZTROPINE MESYLATE BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072265-001 AA
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 2 · 43 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 2026-09-14 22:38:34 2026-08 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072265-001 BENZTROPINE MESYLATE 1MG TABLET / ORAL AA 1989-02-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 2 of 2 · 35 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BENZTROPINE MESYLATE BENZTROPINE MESYLATE QUAGEN PHARMACEUTICALS LLC e1f0a249-e660-4592-9ffc-1c02b1022778 2025-06-17 Warnings, Adverse reactions Name fallback brand name: BENZTROPINE MESYLATE generic name: BENZTROPINE MESYLATE BENZTROPINE MESYLATE BENZTROPINE MESYLATE Marlex PHARMACEUTICAL, INC 31bbcbfa-dc74-99e2-e063-6394a90aa608 2025-03-01 Warnings, Adverse reactions Name fallback brand name: BENZTROPINE MESYLATE generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE MESYLATE Major Pharmaceuticals 8b18b66c-2935-4304-8e20-ebf68dee5a1a 2025-01-16 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE MESYLATE Zydus Pharmaceuticals USA Inc. ecaeaadf-0847-4605-a205-a674f75f8bb2 2024-12-20 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate generic name: BENZTROPINE MESYLATE BENZTROPINE MESYLATE BENZTROPINE MESYLATE SUNRISE PHARMACEUTICAL, INC 2c988462-ce77-4e99-b98e-8f6ad519e295 2024-10-16 Warnings, Adverse reactions Name fallback brand name: BENZTROPINE MESYLATE generic name: BENZTROPINE MESYLATE BENZTROPINE MESYLATE BENZTROPINE MESYLATE Fresenius Kabi USA, LLC b03bd28e-3b44-41e4-9a7e-28b9d7975245 2024-10-11 Warnings, Adverse reactions Name fallback brand name: BENZTROPINE MESYLATE generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE MESYLATE Hikma Pharmaceuticals USA Inc. accd7e33-ca6e-46e6-a2ae-20b9bcd8fb89 2024-04-11 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE MESYLATE Hikma Pharmaceuticals USA Inc. 95620f40-5ddf-41b8-80a5-f658248f26f0 2024-04-11 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE MESYLATE A-S Medication Solutions 53b134eb-b341-4fe4-a3ca-90a7da011974 2024-01-07 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE MESYLATE Bryant Ranch Prepack 959363b8-6847-4f6e-9957-6254febb085c 2023-05-30 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE MESYLATE Endo USA, Inc. c19664aa-a797-4192-b5f3-e906a7cac048 2022-03-16 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate generic name: BENZTROPINE MESYLATE BENZTROPINE MESYLATE BENZTROPINE MESYLATE Leading Pharma, LLC fe002ec4-07cb-41ca-a58c-33b3a8682101 2021-11-14 Warnings, Adverse reactions Name fallback brand name: BENZTROPINE MESYLATE generic name: BENZTROPINE MESYLATE BENZTROPINE MESYLATE BENZTROPINE MESYLATE Aphena Pharma Solutions - Tennessee, LLC f82c6455-f36b-49d7-881e-6601d513d846 2021-01-21 Warnings, Adverse reactions Name fallback brand name: BENZTROPINE MESYLATE generic name: BENZTROPINE MESYLATE Benztropine Mesylate BENZTROPINE Cipla USA Inc. 3d2732f9-b8a9-4e83-91e7-da616ddcb786 2020-05-01 Warnings, Adverse reactions Name fallback brand name: Benztropine Mesylate BENZTROPINE MESYLATE BENZTROPINE MESYLATE Proficient Rx LP c1044563-2bd2-4f43-a951-25d083b1c679 2019-11-01 Warnings, Adverse reactions Name fallback brand name: BENZTROPINE MESYLATE generic name: BENZTROPINE MESYLATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 53808-0210 BENZTROPINE MESYLATE BENZTROPINE MESYLATE State of Florida DOH Central Pharmacy ANDA Current