Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020453
Company: ANI PHARMS

Products on NDA 20453

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PANDEL	HYDROCORTISONE PROBUTATE	0.1%	CREAM;TOPICAL	Discontinued	None	Yes	No

Labels for NDA 020453

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/25/2017	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020453s007lbl.pdf