Application 040251

Type: ANDA
Sponsor: MIKART

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	ELIXIR;ORAL	2MG/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA		1999-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040251-001	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 1 of 2 · 41 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	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040251-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG/5ML	ELIXIR / ORAL	AA	1999-09-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A040251-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040251-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040251-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040251-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040251-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040251-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040251-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040251-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040251-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040251-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040251-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040251-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040251-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040251-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040251-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040251-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040251-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040251-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040251-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040251-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040251-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040251-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040251-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040251-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040251-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040251-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040251-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040251-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040251-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040251-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040251-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040251-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040251-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040251-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040251-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040251-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040251-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040251-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040251-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040251-001	AA	1	`cb3db0bc1861…`

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	Chartwell RX, LLC	e8e2ac3b-80dc-4449-9365-2586d6d57e10	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040251 application number: ANDA040251
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Akorn	294cd88d-d9e8-4938-b4be-c3adc4a35de0	2022-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040251 application number: ANDA040251 ndc (product): 61748-054

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46672-635	trihexyphenidyl hydrochloride	trihexyphenidyl hydrochloride	Mikart, Inc.	ANDA	Current
46672-635	trihexyphenidyl hydrochloride	trihexyphenidyl hydrochloride	Mikart, LLC	ANDA	Current
61748-054	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Akorn	ANDA	Current
61748-054	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	VersaPharm, Inc. - An Akorn Company	ANDA	Current
61748-054	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	Versapharm Incorporated	ANDA	Current
70518-3288	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
38872	ORIG	2004-06-28
22105	ORIG	2003-07-30
29900	ORIG	1999-09-27