Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016968
Company: ALCON

Products on NDA 16968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIOSTAT	CARBACHOL	0.01%	SOLUTION;INTRAOCULAR	Prescription	None	Yes	Yes

Labels for NDA 016968

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/21/2016	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016968s029lbl.pdf
11/10/2004	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16968s022lbl.pdf
11/25/2002	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16968slr020_Miostat_lbl.pdf