Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022432
Company: QUESTCOR PHARMA

• Medication Guide

• Summary Review

Products on NDA 022432

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
H.P. ACTHAR GEL	REPOSITORY CORTICOTROPIN	80 UNITS/ML	INJECTABLE; INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022432

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2010	ORIG-1	Approval	Type 6 - New Indication (no longer used)	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)	See NDA 008372 for the most up-to-date labeling	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022432s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432_hp_acthar_gel_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432Orig1s0900SumR.pdf

Labels for NDA 022432

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2010	ORIG-1	Approval	Label (PDF)	See NDA 008372 for the most up-to-date labeling	https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022432s000lbl.pdf