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FDA ANDA · ANDA090287

BENZTROPINE MESYLATE

Sponsor: HIKMA FARMACEUTICA

APPLICATION
ANDA090287
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-31
LATEST ACTION
2014-02-25
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BENZTROPINE MESYLATEPrescription
BENZTROPINE MESYLATE 1MG/ML · INJECTABLE · INJECTION

Approval history

2014-02-25Labeling · Supplement 4 · standardAP
2009-08-31OriginalAP
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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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