Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083722
Company: INTL MEDICATION

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHYTONADIONE PHYTONADIONE 1MG/0.5ML INJECTABLE;INJECTION Prescription BP Yes 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
03/01/1976 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
04/18/2003 SUPPL-23 Labeling

Label is not available on this site.
03/06/2002 SUPPL-21 Labeling

Label is not available on this site.
01/04/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
09/19/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
11/10/1994 SUPPL-18 Labeling

Label is not available on this site.
06/17/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
01/14/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
02/03/1994 SUPPL-14 Labeling

Label is not available on this site.
10/29/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
08/30/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.
12/09/1992 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/083722Orig1s011.pdf
08/05/1987 SUPPL-9 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/083722Orig1s009.pdf
07/11/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

PHYTONADIONE

There are no Therapeutic Equivalents.

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