Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087954
Company: HOSPIRA

Products on ANDA 087954

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VITAMIN K1	PHYTONADIONE	1MG/0.5ML	INJECTABLE;INJECTION	Prescription	BP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087954

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/1983	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
03/06/2026	SUPPL-33	Labeling-Package Insert		Label is not available on this site.
10/06/2004	SUPPL-17	Labeling		Label is not available on this site.
02/27/2003	SUPPL-15	Labeling		Label is not available on this site.
07/19/1999	SUPPL-14	Labeling		Label is not available on this site.
11/02/1995	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
12/02/1993	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/14/1993	SUPPL-11	Labeling		Label is not available on this site.
08/28/1992	SUPPL-10	Labeling		Label is not available on this site.
12/28/1989	SUPPL-9	Labeling		Label is not available on this site.
08/15/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/19/1989	SUPPL-7	Labeling		Label is not available on this site.
02/22/1989	SUPPL-6	Labeling		Label is not available on this site.
11/04/1988	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/04/1988	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/27/1984	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/07/1983	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087954

VITAMIN K1

There are no Therapeutic Equivalents.