Application 084364

Type: ANDA
Sponsor: WATSON LABS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084364-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084364-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS, Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A084364-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A084364-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084364-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084364-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084364-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084364-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084364-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084364-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084364-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084364-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084364-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084364-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084364-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084364-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084364-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084364-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084364-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084364-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084364-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084364-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084364-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084364-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084364-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084364-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084364-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084364-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084364-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084364-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084364-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084364-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084364-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084364-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084364-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084364-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084364-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084364-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084364-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084364-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084364-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084364-001	AA	1	`3a93d1ddd44b…`

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
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	3e71b957-9495-4583-8f00-99eac715ff85	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084364 application number: ANDA084364 ndc (product): 70518-1657
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	3ed3cdf1-1745-4c6f-bb90-fb7d9471270d	2026-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084364 application number: ANDA084364 ndc (product): 70518-1140
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Actavis Pharma, Inc.	a44d7803-164d-4a67-9356-581c45de8596	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084364 application number: ANDA084364 ndc (product): 0591-5337

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-5337	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Actavis Pharma, Inc.	ANDA	Current
53808-0696	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
70518-1140	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1140	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1140	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1140	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1140	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1657	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1657	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1657	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1657	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1657	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current