Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087954
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VITAMIN K1 PHYTONADIONE 1MG/0.5ML INJECTABLE;INJECTION Prescription BP No Yes
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
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.

VITAMIN K1

There are no Therapeutic Equivalents.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English