Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050095
Company: EPIC PHARMA LLC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CAPASTAT SULFATE	CAPREOMYCIN SULFATE	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-78	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050095s078lbl.pdf
01/16/2019	SUPPL-72	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/050095s072lbl.pdf
07/24/2008	SUPPL-62	Labeling	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050095s062lbl.pdf
06/11/2003	SUPPL-44	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/50095slr044_capastat_lbl.pdf