Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071961
Company: VPNA

Products on ANDA 071961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROPRESS	SODIUM NITROPRUSSIDE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/1988	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071961s013lbl.pdf
02/10/1995	SUPPL-4	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/071961Orig1S004MicroR.pdf
02/24/1994	SUPPL-3	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/071961Orig1S003ChemR.pdf
04/09/1992	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/071961Orig1S002LBL.pdf
01/29/1991	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 071961

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/071961s013lbl.pdf