Application 040337

Type: ANDA
Sponsor: HIKMA PHARMS

Application Products#

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

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

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
A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL			2000-02-16
A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL			2000-02-16

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040337-001	TRIHEXYPHENIDYL HYDROCHLORIDE	5MG	TABLET / ORAL	2000-02-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040337-002	TRIHEXYPHENIDYL HYDROCHLORIDE	2MG	TABLET / ORAL	2000-02-16	`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 · 12 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	Name fallback brand name: TRIHEXYPHENIDYL HYDROCHLORIDE generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	b60ef86c-b8b6-4530-baaf-d4671ce961af	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: TRIHEXYPHENIDYL HYDROCHLORIDE generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Chartwell RX, LLC	e8e2ac3b-80dc-4449-9365-2586d6d57e10	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	86a65e8a-10f4-4f12-8e65-2edf398daeaa	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	3e71b957-9495-4583-8f00-99eac715ff85	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	REMEDYREPACK INC.	3ed3cdf1-1745-4c6f-bb90-fb7d9471270d	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	9036c9f0-6d2d-4d0f-a20e-e36f9be228f7	2024-11-19	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Actavis Pharma, Inc.	a44d7803-164d-4a67-9356-581c45de8596	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Golden State Medical Supply Inc.	9040cb3b-13d2-e46d-e053-2a95a90ae9e6	2023-09-26	Warnings, Adverse reactions	Name fallback brand name: TRIHEXYPHENIDYL HYDROCHLORIDE generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Akorn	294cd88d-d9e8-4938-b4be-c3adc4a35de0	2022-06-21	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl Hydrochloride	TRIHEXYPHENIDYL HYDROCHLORIDE	Natco Pharma Limited	b7e4200c-feff-4537-aad1-cf9989fd8c14	2019-10-25	Warnings, Adverse reactions	Name fallback brand name: Trihexyphenidyl Hydrochloride generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDE	TRIHEXYPHENIDYL HYDROCHLORIDE	Novitium Pharma LLC	83608c13-509d-448b-8559-5f5e8a9a0d75	2019-01-28	Warnings, Adverse reactions	Name fallback brand name: TRIHEXYPHENIDYL HYDROCHLORIDE generic name: TRIHEXYPHENIDYL HYDROCHLORIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-1763	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	West-ward Pharmaceutical Corp	ANDA	Current
0143-1764	Trihexyphenidyl Hydrochloride	Trihexyphenidyl Hydrochloride	West-ward Pharmaceutical Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7629	ORIG	2000-02-16