Application 090294

Type: ANDA
Sponsor: INVAGEN PHARMS

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	Approval date
A090294-001	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29
A090294-002	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29
A090294-003	BENZTROPINE MESYLATE	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090294-002	BENZTROPINE MESYLATE	1MG	TABLET / ORAL	2010-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090294-003	BENZTROPINE MESYLATE	2MG	TABLET / ORAL	2010-03-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090294-001	BENZTROPINE MESYLATE	0.5MG	TABLET / ORAL	2010-03-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090294-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090294-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090294-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090294-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090294-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090294-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090294-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090294-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090294-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090294-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090294-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090294-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090294-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090294-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090294-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090294-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090294-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090294-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090294-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090294-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090294-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090294-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090294-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090294-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090294-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090294-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090294-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090294-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090294-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090294-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090294-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090294-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090294-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090294-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090294-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090294-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090294-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090294-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090294-003	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090294-001	AA	1	`6a51e52b5d6a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benztropine Mesylate	BENZTROPINE	Cipla USA Inc.	3d2732f9-b8a9-4e83-91e7-da616ddcb786	2020-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090294 application number: ANDA090294 ndc (product): 69097-832 ndc (product): 69097-827 ndc (product): 69097-826

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
31722-218	Benztropine Mesylate	benztropine mesylate	Camber Pharmaceutical, Inc.	ANDA	Current
31722-219	Benztropine Mesylate	benztropine mesylate	Camber Pharmaceutical, Inc.	ANDA	Current
31722-220	Benztropine Mesylate	benztropine mesylate	Camber Pharmaceutical, Inc.	ANDA	Current
69097-826	Benztropine Mesylate	Benztropine	Cipla USA Inc.	ANDA	Current
69097-826	Benztropine Mesylate	Benztropine	Cipla USA Inc.	ANDA	Current
69097-827	Benztropine Mesylate	Benztropine	Cipla USA Inc.	ANDA	Current
69097-827	Benztropine Mesylate	Benztropine	Cipla USA Inc.	ANDA	Current
69097-832	Benztropine Mesylate	Benztropine	Cipla USA Inc.	ANDA	Current
69097-832	Benztropine Mesylate	Benztropine	Cipla USA Inc.	ANDA	Current
70518-1005	Benztropine Mesylate	Benztropine	REMEDYREPACK INC.	ANDA	Current
70518-1005	Benztropine Mesylate	Benztropine	REMEDYREPACK INC.	ANDA	Current
70518-1056	Benztropine Mesylate	Benztropine	REMEDYREPACK INC.	ANDA	Current
70518-1056	Benztropine Mesylate	Benztropine	REMEDYREPACK INC.	ANDA	Current
70518-1217	Benztropine Mesylate	Benztropine	REMEDYREPACK INC.	ANDA	Current
70518-1217	Benztropine Mesylate	Benztropine	REMEDYREPACK INC.	ANDA	Current