Application 009193

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	COGENTIN	BENZTROPINE MESYLATE	TABLET;ORAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	COGENTIN	BENZTROPINE MESYLATE	TABLET;ORAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	COGENTIN	BENZTROPINE MESYLATE	TABLET;ORAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	RLD / RS
N009193-002	COGENTIN	BENZTROPINE MESYLATE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N009193-003	COGENTIN	BENZTROPINE MESYLATE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N009193-004	COGENTIN	BENZTROPINE MESYLATE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009193-003	COGENTIN	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N009193-004	COGENTIN	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N009193-002	COGENTIN	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`

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 2 · 34 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benztropine Mesylate	BENZTROPINE MESYLATE	Unit Dose Solutions, Inc.	53c02a89-012c-e724-e063-6294a90acc75	2026-08-17	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	241479dd-91bf-455a-80a1-1bb2d1c8156d	2026-07-28	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	01688e6f-7b22-41bf-9a85-1c88d90f99b6	2026-06-29	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	REMEDYREPACK INC.	09e3e099-0b29-4ab5-bf35-5e41355dd454	2026-06-23	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	52bd605a-6a28-c2ec-e063-6294a90a8371	2026-05-26	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	513b1f4c-d253-6ad7-e063-6394a90a1dab	2026-05-07	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	512ada3e-4b85-d989-e063-6394a90a9d54	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	50c61b1d-49d6-37f2-e063-6294a90a0590	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	5035534e-e15c-8f06-e063-6294a90a5003	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	bac9dfb7-aa09-4841-9e8f-cc41bb438fe2	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	REMEDYREPACK INC.	7430b584-2812-4af5-994a-33dd1afed476	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	Navinta LLC	f92fbafa-314d-4449-831f-26108339e6b2	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	DIRECT RX	9b93035b-34d6-4084-ba73-5dea72f9d124	2026-03-17	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Bryant Ranch Prepack	ae749a71-d253-474d-a26c-bec780c5b09c	2026-02-16	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	ScieGen Pharmaceuticals Inc	1ead16a7-88ed-407d-b25a-0d9a1d9da5ef	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Bryant Ranch Prepack	9270d14c-b885-4679-8871-6f2547450398	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	Bryant Ranch Prepack	284e78af-7544-4c4a-8081-74e45501dc76	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	Chartwell RX, LLC.	c002005d-a478-48d4-b345-cb87edcb061f	2025-12-09	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE
Benztropine Mesylate	BENZTROPINE MESYLATE	American Health Packaging	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: BENZTROPINE MESYLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11869	ORIG	2003-04-16
178	SUPPL	2001-05-22