Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020587
Company: SCIARRA LABS

Products on NDA 020587

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SCLEROSOL	TALC	4GM/SPRAY	AEROSOL;INTRAPLEURAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020587

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/24/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020587_sclerosol_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2012	SUPPL-6	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020587s006lbl.pdf
02/23/2001	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/23/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/02/2000	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020587

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2012	SUPPL-6	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020587s006lbl.pdf