APPLICATION
ANDA040103
TYPE
ANDA
ORIGINAL APPROVAL
1996-12-12
LATEST ACTION
2024-08-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 2MG · TABLET · ORAL
BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 0.5MG · TABLET · ORAL
BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 1MG · TABLET · ORAL
Approval history
2024-08-02Manufacturing (CMC) · Supplement 24 · unknownAP
2005-02-10Labeling · Supplement 6AP
2002-11-12Labeling · Supplement 2AP
1998-03-06Labeling · Supplement 1AP
1996-12-12OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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