Application 091630

Type: ANDA
Sponsor: NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	TABLET;ORAL	2MG	No	No
002	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	TABLET;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA		2010-11-17
A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA		2010-11-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091630-001	AA
A091630-002	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 3 · 84 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	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091630-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	2010-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091630-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2010-11-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091630-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091630-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091630-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091630-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091630-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091630-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091630-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091630-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091630-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091630-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091630-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091630-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091630-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091630-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091630-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091630-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091630-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091630-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091630-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091630-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091630-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091630-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091630-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091630-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091630-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091630-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091630-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091630-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091630-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091630-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091630-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091630-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091630-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091630-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091630-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091630-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091630-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091630-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091630-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091630-002	AA	1	`bb7c543d1eb4…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Bionpharma Inc.	4d4d473e-4f84-43e7-bb17-49e8dc1e97fd	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091630 application number: ANDA091630 ndc (product): 69452-241 ndc (product): 69452-242
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Natco Pharma Limited	b7e4200c-feff-4537-aad1-cf9989fd8c14	2019-10-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091630 application number: ANDA091630 ndc (product): 63850-0022 ndc (product): 63850-0021

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16571-160	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-160	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-161	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
16571-161	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Rising Pharmaceuticals, Inc.	ANDA	Current
50090-3101	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	A-S Medication Solutions	ANDA	Current
63850-0021	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Natco Pharma Limited	ANDA	Current
63850-0021	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Natco Pharma Limited-Pharma Division	ANDA	Current
63850-0022	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Natco Pharma Limited	ANDA	Current
63850-0022	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Natco Pharma Limited-Pharma Division	ANDA	Current
64725-0161	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	TYA Pharmaceuticals	ANDA	Current
69452-241	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Bionpharma Inc.	ANDA	Current
69452-242	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Bionpharma Inc.	ANDA	Current
70518-0569	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0569	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2878	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2878	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2880	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2880	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2880	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current