APPLICATION
ANDA089059
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-10
LATEST ACTION
2001-12-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 1MG · TABLET · ORAL
Approval history
2001-12-10Labeling · Supplement 11AP
2001-05-29Manufacturing (CMC) · Supplement 10AP
2000-07-07Manufacturing (CMC) · Supplement 9AP
1998-10-27Labeling · Supplement 8AP
1998-03-09Labeling · Supplement 4AP
1997-08-13Manufacturing (CMC) · Supplement 6AP
1997-08-13Manufacturing (CMC) · Supplement 7AP
1994-05-11Manufacturing (CMC) · Supplement 5AP
1992-09-24Manufacturing (CMC) · Supplement 2AP
1992-09-24Bioequivalence · Supplement 3AP
1991-02-23Manufacturing (CMC) · Supplement 1AP
1988-08-10OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.