Application 040254

Type: ANDA
Sponsor: NOVITIUM PHARMA

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 1.

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
A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA		1998-12-24
A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA		1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040254-001	AA
A040254-002	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 · 82 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	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040254-001	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	AA	1998-12-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040254-002	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1998-12-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A040254-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040254-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040254-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040254-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040254-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040254-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040254-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040254-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040254-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040254-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040254-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040254-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040254-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040254-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040254-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040254-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040254-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040254-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040254-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040254-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040254-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040254-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040254-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040254-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040254-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040254-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040254-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040254-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040254-002	AA	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	c25ea809-5bdf-4917-97f1-610059fbd0b7	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254 ndc (product): 70518-2409
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	b60ef86c-b8b6-4530-baaf-d4671ce961af	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254 ndc (product): 70518-2410
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	9040cb3b-13d2-e46d-e053-2a95a90ae9e6	2023-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254 ndc (product): 51407-266 ndc (product): 51407-265
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Novitium Pharma LLC	83608c13-509d-448b-8559-5f5e8a9a0d75	2019-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040254 application number: ANDA040254 ndc (product): 70954-211 ndc (product): 70954-212

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-6240	Trihexyphenidyl Hydrochloride	trihexyphenidyl hydrochloride	Qualitest Pharmaceuticals	ANDA	Current
50090-5205	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
51407-265	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	ANDA	Current
51407-265	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	ANDA	Current
51407-265	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	ANDA	Current
51407-266	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	ANDA	Current
51407-266	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	ANDA	Current
51407-266	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	ANDA	Current
53808-0633	Trihexyphenidyl Hydrochloride	trihexyphenidyl hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0634	Trihexyphenidyl Hydrochloride	trihexyphenidyl hydrochloride	State of Florida DOH Central Pharmacy	ANDA	Current
54738-554	Trihexyphenidyl Hydrochloride	trihexyphenidyl hydrochloride	Richmond Pharmaceuticals, Inc.	ANDA	Current
54738-555	Trihexyphenidyl Hydrochloride	trihexyphenidyl hydrochloride	Richmond Pharmaceuticals, Inc.	ANDA	Current
70518-0357	Trihexyphenidyl Hydrochloride	trihexyphenidyl hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-2409	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2409	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2409	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2409	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2410	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2410	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2410	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70954-211	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Novitium Pharma LLC	ANDA	Current
70954-212	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Novitium Pharma LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
17755	ORIG	2004-06-28
42601	ORIG	2003-07-31
29901	ORIG	1998-12-24