Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

Products on NDA 021388

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021388

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2003	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21388_SterileTalclbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21388ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-388_SterileTalc.html

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021388s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021388Orig1s002ltr.pdf

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