FDA.reportPublic FDA data

Application 040706

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZTROPINE MESYLATEBENZTROPINE MESYLATETABLET;ORAL2MGNoNo
002BENZTROPINE MESYLATEBENZTROPINE MESYLATETABLET;ORAL0.5MGNoNo
003BENZTROPINE MESYLATEBENZTROPINE MESYLATETABLET;ORAL1MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040706-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORAL2008-02-14
A040706-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORAL2008-02-14
A040706-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORAL2008-02-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040706-001BENZTROPINE MESYLATE2MGTABLET / ORAL2008-02-14a50c72e98297…
2026-08-01 22:54:322026-06A040706-002BENZTROPINE MESYLATE0.5MGTABLET / ORAL2008-02-14a50c72e98297…
2026-08-01 22:54:322026-06A040706-003BENZTROPINE MESYLATE1MGTABLET / ORAL2008-02-14a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.241479dd-91bf-455a-80a1-1bb2d1c8156d2026-07-28Warnings, Adverse reactionsName fallback
brand name: BENZTROPINE MESYLATE
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.01688e6f-7b22-41bf-9a85-1c88d90f99b62026-06-29Warnings, Adverse reactionsName fallback
brand name: BENZTROPINE MESYLATE
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEREMEDYREPACK INC.09e3e099-0b29-4ab5-bf35-5e41355dd4542026-06-23Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEUnit Dose Solutions, Inc.53c02a89-012c-e724-e063-6294a90acc752026-06-08Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC52bd605a-6a28-c2ec-e063-6294a90a83712026-05-26Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC513b1f4c-d253-6ad7-e063-6394a90a1dab2026-05-07Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC512ada3e-4b85-d989-e063-6394a90a9d542026-05-06Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC50c61b1d-49d6-37f2-e063-6294a90a05902026-05-01Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC5035534e-e15c-8f06-e063-6294a90a50032026-04-24Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsbac9dfb7-aa09-4841-9e8f-cc41bb438fe22026-04-15Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEREMEDYREPACK INC.7430b584-2812-4af5-994a-33dd1afed4762026-03-24Warnings, Adverse reactionsName fallback
brand name: BENZTROPINE MESYLATE
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATENavinta LLCf92fbafa-314d-4449-831f-26108339e6b22026-03-17Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEDIRECT RX9b93035b-34d6-4084-ba73-5dea72f9d1242026-03-17Warnings, Adverse reactionsName fallback
brand name: BENZTROPINE MESYLATE
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepackae749a71-d253-474d-a26c-bec780c5b09c2026-02-16Warnings, Adverse reactionsName fallback
brand name: BENZTROPINE MESYLATE
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATENCS HealthCare of KY, LLC dba Vangard Labsdf0647b8-2aa7-4aa4-9ba3-82c28698e7c52026-01-23Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEScieGen Pharmaceuticals Inc1ead16a7-88ed-407d-b25a-0d9a1d9da5ef2026-01-09Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack9270d14c-b885-4679-8871-6f25474503982026-01-07Warnings, Adverse reactionsName fallback
brand name: BENZTROPINE MESYLATE
generic name: BENZTROPINE MESYLATE
BENZTROPINE MESYLATEBENZTROPINE MESYLATEBryant Ranch Prepack284e78af-7544-4c4a-8081-74e45501dc762026-01-07Warnings, Adverse reactionsName fallback
brand name: BENZTROPINE MESYLATE
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEChartwell RX, LLC.c002005d-a478-48d4-b345-cb87edcb061f2025-12-09Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE
Benztropine MesylateBENZTROPINE MESYLATEAmerican Health Packagingb7f915a9-cd53-4a74-8ee5-35ee5c5c991e2025-11-18Warnings, Adverse reactionsName fallback
brand name: Benztropine Mesylate
generic name: BENZTROPINE MESYLATE