Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016750
Company: AMPHASTAR PHARMS INC

Products on NDA 16750

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORTROSYN	COSYNTROPIN	0.25MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Labels for NDA 016750

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/14/2021	SUPPL-32	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf
12/14/2021	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/016750Orig1s032lbl.pdf