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FDA NDA · NDA022432

H.P. ACTHAR GEL

Sponsor: QUESTCOR PHARMA

APPLICATION
NDA022432
TYPE
NDA
ORIGINAL APPROVAL
2010-10-15
LATEST ACTION
2010-10-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

H.P. ACTHAR GELPrescription
REPOSITORY CORTICOTROPIN 80 UNITS/ML · INJECTABLE · INJECTION

Approval history

2010-10-15Type 6 - New Indication (no longer used) · Original · standardLabelAP
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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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