Application 040103

Type: ANDA
Sponsor: UPSHER SMITH LABS

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 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	Approval date
A040103-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12
A040103-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12
A040103-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040103-001	AA
A040103-002	AA
A040103-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	AA	1996-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	AA	1996-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	AA	1996-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL		1996-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL		1996-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL		1996-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL		1996-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040103-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL		1996-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040103-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL		1996-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040103-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL		1996-12-12	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040103-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040103-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040103-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-002	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040103-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-002	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040103-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040103-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-002	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040103-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-002	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040103-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-002	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040103-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-002	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040103-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-002	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040103-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-002	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040103-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-002	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040103-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040103-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-002	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040103-003	AA	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040103-001	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040103-002	AA	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A040103-003	AA	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	513b1f4c-d253-6ad7-e063-6394a90a1dab	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040103 application number: ANDA040103
Benztropine Mesylate	BENZTROPINE MESYLATE	Coupler LLC	50c61b1d-49d6-37f2-e063-6294a90a0590	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040103 application number: ANDA040103
Benztropine Mesylate	BENZTROPINE MESYLATE	ScieGen Pharmaceuticals Inc	1ead16a7-88ed-407d-b25a-0d9a1d9da5ef	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040103 application number: ANDA040103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7675	Benztropine Mesylate	Benztropine Mesylate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7676	Benztropine Mesylate	benztropine mesylate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7677	Benztropine Mesylate	benztropine mesylate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0832-1080	Benztropine Mesylate	benztropine mesylate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1081	Benztropine Mesylate	benztropine mesylate	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-1082	Benztropine Mesylate	benztropine mesylate	Upsher-Smith Laboratories, LLC	ANDA	Current
53808-0826	Benztropine Mesylate	benztropine mesylate	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0904	benztropine mesylate	BENZTROPINE MESYLATE	State of Florida DOH Central Pharmacy	ANDA	Current
67046-042	benztropine mesylate	benztropine mesylate	Contract Pharmacy Services-PA	ANDA	Current
67046-043	benztropine mesylate	benztropine mesylate	Contract Pharmacy Services-PA	ANDA	Current