Application 091152

Type: ANDA
Sponsor: LUITPOLD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	INJECTABLE;INJECTION	1MG/ML	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
A091152-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION			2010-03-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091152-001	BENZTROPINE MESYLATE	1MG/ML	INJECTABLE / INJECTION	2010-03-29	`f41ea6bd6efb…`

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
0517-0785	Benztropine Mesylate	Benztropine Mesylate	American Regent, Inc.	ANDA	Current