Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071847
Company: HOSPIRA

Products on ANDA 071847

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NITROGLYCERIN IN DEXTROSE 5%	NITROGLYCERIN	20MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071847

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/1990	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
10/27/2007	SUPPL-20	Labeling		Label is not available on this site.
05/31/2001	SUPPL-16	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
05/31/2001	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
04/20/2001	SUPPL-14	Labeling		Label is not available on this site.
06/26/2001	SUPPL-13	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
06/26/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
05/31/2001	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/26/2001	SUPPL-10	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/27/2000	SUPPL-9	Labeling		Label is not available on this site.
04/23/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/23/1999	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/24/1996	SUPPL-5	Labeling		Label is not available on this site.
11/02/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/20/1996	SUPPL-2	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/14/1996	SUPPL-1	Labeling		Label is not available on this site.