APPLICATION
ANDA081265
TYPE
ANDA
ORIGINAL APPROVAL
1992-01-23
LATEST ACTION
2002-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 1MG · TABLET · ORAL
BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 0.5MG · TABLET · ORAL
BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 2MG · TABLET · ORAL
Approval history
2002-05-15Labeling · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
1998-03-25Labeling · Supplement 7AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-02-24Manufacturing (CMC) · Supplement 5AP
1996-10-31Manufacturing (CMC) · Supplement 4AP
1995-06-22Manufacturing (CMC) · Supplement 3AP
1994-01-12Manufacturing (CMC) · Supplement 2AP
1993-07-06Labeling · Supplement 1AP
1992-01-23OriginalAP
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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