Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021388
Company: SCIARRA LABS

Products on NDA 21388

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TALC	TALC	5GM/BOT	POWDER;INTRAPLEURAL	Prescription	None	Yes	Yes

Labels for NDA 021388

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/13/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021388s002lbl.pdf
12/15/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21388_SterileTalclbl.pdf