FDA.reportPublic FDA data

Application 040103

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

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

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
A040103-001BENZTROPINE MESYLATEBENZTROPINE MESYLATE0.5MGTABLET / ORALAA1996-12-12
A040103-002BENZTROPINE MESYLATEBENZTROPINE MESYLATE1MGTABLET / ORALAA1996-12-12
A040103-003BENZTROPINE MESYLATEBENZTROPINE MESYLATE2MGTABLET / ORALAA1996-12-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040103-001AA
A040103-002AA
A040103-003AA

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 22:54:322026-06A040103-001BENZTROPINE MESYLATE0.5MGTABLET / ORALAA1996-12-12a50c72e98297…
2026-08-01 22:54:322026-06A040103-002BENZTROPINE MESYLATE1MGTABLET / ORALAA1996-12-12a50c72e98297…
2026-08-01 22:54:322026-06A040103-003BENZTROPINE MESYLATE2MGTABLET / ORALAA1996-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040103-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A040103-002AA1a50c72e98297…
2026-08-01 22:54:322026-06A040103-003AA1a50c72e98297…

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC513b1f4c-d253-6ad7-e063-6394a90a1dab2026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040103
application number: ANDA040103
Benztropine MesylateBENZTROPINE MESYLATECoupler LLC50c61b1d-49d6-37f2-e063-6294a90a05902026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040103
application number: ANDA040103
Benztropine MesylateBENZTROPINE MESYLATEScieGen Pharmaceuticals Inc1ead16a7-88ed-407d-b25a-0d9a1d9da5ef2026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040103
application number: ANDA040103

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-7675Benztropine MesylateBenztropine MesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7676Benztropine Mesylatebenztropine mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7677Benztropine Mesylatebenztropine mesylateNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0832-1080Benztropine Mesylatebenztropine mesylateUpsher-Smith Laboratories, LLCANDACurrent
0832-1081Benztropine Mesylatebenztropine mesylateUpsher-Smith Laboratories, LLCANDACurrent
0832-1082Benztropine Mesylatebenztropine mesylateUpsher-Smith Laboratories, LLCANDACurrent
53808-0826Benztropine Mesylatebenztropine mesylateState of Florida DOH Central PharmacyANDACurrent
53808-0904benztropine mesylateBENZTROPINE MESYLATEState of Florida DOH Central PharmacyANDACurrent
67046-042benztropine mesylatebenztropine mesylateContract Pharmacy Services-PAANDACurrent
67046-043benztropine mesylatebenztropine mesylateContract Pharmacy Services-PAANDACurrent