Application 040715

Type: ANDA
Sponsor: VINTAGE

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	No
002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	TABLET;ORAL	1MG	No	No
003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	TABLET;ORAL	2MG	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	Approval date
A040715-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27
A040715-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27
A040715-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040715-001	AA
A040715-002	AA
A040715-003	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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	2007-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	2007-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040715-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	2007-08-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040715-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040715-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040715-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040715-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040715-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040715-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040715-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040715-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040715-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040715-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040715-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040715-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040715-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-002	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040715-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-002	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040715-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-002	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040715-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040715-001	AA	1	`8072bd15b7f6…`

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 · 12 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	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	52bd605a-6a28-c2ec-e063-6294a90a8371	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	512ada3e-4b85-d989-e063-6394a90a9d54	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	5035534e-e15c-8f06-e063-6294a90a5003	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	bac9dfb7-aa09-4841-9e8f-cc41bb438fe2	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	DIRECT RX	9b93035b-34d6-4084-ba73-5dea72f9d124	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715 ndc (product): 61919-128
Benztropine Mesylate	BENZTROPINE MESYLATE	NCS HealthCare of KY, LLC dba Vangard Labs	df0647b8-2aa7-4aa4-9ba3-82c28698e7c5	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	American Health Packaging	b7f915a9-cd53-4a74-8ee5-35ee5c5c991e	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715 ndc (product): 68084-389 ndc (product): 68084-381
Benztropine Mesylate	BENZTROPINE MESYLATE	Major Pharmaceuticals	8b18b66c-2935-4304-8e20-ebf68dee5a1a	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	A-S Medication Solutions	53b134eb-b341-4fe4-a3ca-90a7da011974	2024-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Bryant Ranch Prepack	959363b8-6847-4f6e-9957-6254febb085c	2023-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715
Benztropine Mesylate	BENZTROPINE MESYLATE	Endo USA, Inc.	c19664aa-a797-4192-b5f3-e906a7cac048	2022-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040715 application number: ANDA040715 ndc (product): 0603-2434 ndc (product): 0603-2433 ndc (product): 0603-2435

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-2433	Benztropine Mesylate	benztropine mesylate	Par Pharmaceutical, Inc.	ANDA	Current
0603-2434	Benztropine Mesylate	benztropine mesylate	Par Pharmaceutical, Inc.	ANDA	Current
0603-2435	Benztropine Mesylate	benztropine mesylate	Par Pharmaceutical, Inc.	ANDA	Current
0603-2435	Benztropine Mesylate	benztropine mesylate	Qualitest Pharmaceuticals	ANDA	Current
0603-2435	Benztropine Mesylate	benztropine mesylate	Par Pharmaceutical, Inc.	ANDA	Current
53808-0825	Benztropine Mesylate	benztropine mesylate	State of Florida DOH Central Pharmacy	ANDA	Current
61919-128	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	DIRECT RX	ANDA	Current
61919-128	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	DIRECT RX	ANDA	Current
63629-9422	Benztropine Mesylate	benztropine mesylate	Bryant Ranch Prepack	ANDA	Current
64725-2435	Benztropine Mesylate	benztropine mesylate	TYA Pharmaceuticals	ANDA	Current
68084-381	Benztropine Mesylate	Benztropine Mesylate	American Health Packaging	ANDA	Current
68084-389	Benztropine Mesylate	Benztropine Mesylate	American Health Packaging	ANDA	Current
70518-0129	Benztropine Mesylate	benztropine mesylate	REMEDYREPACK INC.	ANDA	Current
70518-1455	Benztropine Mesylate	benztropine mesylate	REMEDYREPACK INC.	ANDA	Current
70518-1455	Benztropine Mesylate	benztropine mesylate	REMEDYREPACK INC.	ANDA	Current