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FDA BLA · BLA020162

ACTHREL

Sponsor: FERRING

APPLICATION
BLA020162
TYPE
BLA
ORIGINAL APPROVAL
1996-05-23
LATEST ACTION
2015-09-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ACTHRELPrescription
CORTICORELIN OVINE TRIFLUTATE EQ 0.1MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2015-09-01Labeling · Supplement 10 · 901 required — Label ↗AP
2014-01-31Manufacturing (CMC) · Supplement 9 · priorityAP
2002-07-16Manufacturing (CMC) · Supplement 3 · priorityAP
1997-04-24Manufacturing (CMC) · Supplement 2 · priorityAP
1997-04-04Manufacturing (CMC) · Supplement 1 · priorityAP
1996-05-23Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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