FDA.reportPublic FDA data

Application 080381

Type
ANDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TREMINTRIHEXYPHENIDYL HYDROCHLORIDETABLET;ORAL2MGNoNo
003TREMINTRIHEXYPHENIDYL HYDROCHLORIDETABLET;ORAL5MGNoNo

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
A080381-001TREMINTRIHEXYPHENIDYL HYDROCHLORIDE2MGTABLET / ORALApproved before 1982
A080381-003TREMINTRIHEXYPHENIDYL HYDROCHLORIDE5MGTABLET / ORALApproved before 1982

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 UTC2022-10A080381-001TREMIN2MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A080381-003TREMIN5MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080381-001TREMIN2MGTABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A080381-003TREMIN5MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080381-001TREMIN2MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080381-003TREMIN5MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080381-001TREMIN2MGTABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080381-003TREMIN5MGTABLET / ORALApproved before 1982a50c72e98297…

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

Reported adverse events (FAERS/openFDA)#

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