FDA.reportPublic FDA data

Application 040337

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDETABLET;ORAL5MGNoNo
002TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDETABLET;ORAL2MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040337-001TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16
A040337-002TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16e64feba35796…
2022-09-29 23:25 UTC2022-09A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040337-001TRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORAL2000-02-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040337-002TRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORAL2000-02-16a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.c25ea809-5bdf-4917-97f1-610059fbd0b72026-07-23Warnings, Adverse reactionsName fallback
brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.b60ef86c-b8b6-4530-baaf-d4671ce961af2026-07-23Warnings, Adverse reactionsName fallback
brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEChartwell RX, LLCe8e2ac3b-80dc-4449-9365-2586d6d57e102026-07-17Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.86a65e8a-10f4-4f12-8e65-2edf398daeaa2026-07-09Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.3e71b957-9495-4583-8f00-99eac715ff852026-07-09Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEREMEDYREPACK INC.3ed3cdf1-1745-4c6f-bb90-fb7d9471270d2026-07-02Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma9036c9f0-6d2d-4d0f-a20e-e36f9be228f72024-11-19Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEActavis Pharma, Inc.a44d7803-164d-4a67-9356-581c45de85962024-02-02Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDEGolden State Medical Supply Inc.9040cb3b-13d2-e46d-e053-2a95a90ae9e62023-09-26Warnings, Adverse reactionsName fallback
brand name: TRIHEXYPHENIDYL HYDROCHLORIDE
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDEAkorn294cd88d-d9e8-4938-b4be-c3adc4a35de02022-06-21Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
Trihexyphenidyl HydrochlorideTRIHEXYPHENIDYL HYDROCHLORIDENatco Pharma Limitedb7e4200c-feff-4537-aad1-cf9989fd8c142019-10-25Warnings, Adverse reactionsName fallback
brand name: Trihexyphenidyl Hydrochloride
generic name: TRIHEXYPHENIDYL HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDETRIHEXYPHENIDYL HYDROCHLORIDENovitium Pharma LLC83608c13-509d-448b-8559-5f5e8a9a0d752019-01-28Warnings, Adverse reactionsName 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1763Trihexyphenidyl HydrochlorideTrihexyphenidyl HydrochlorideWest-ward Pharmaceutical CorpANDACurrent
0143-1764Trihexyphenidyl HydrochlorideTrihexyphenidyl HydrochlorideWest-ward Pharmaceutical CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7629ORIG2000-02-16