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FDA ANDA · ANDA040715

BENZTROPINE MESYLATE

Sponsor: PH HEALTH

APPLICATION
ANDA040715
TYPE
ANDA
ORIGINAL APPROVAL
2007-08-27
LATEST ACTION
2007-08-27
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

2007-08-27OriginalAP
VIEW ON DRUGS@FDA ↗

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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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