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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010104
Company: BAUSCH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPHYTON PHYTONADIONE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/30/1955 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/010104Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2021 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010104s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/010104Orig1s031ltr.pdf
03/16/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
01/21/2010 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010104s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010104s028ltr.pdf
12/09/2004 SUPPL-23 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf
02/09/2004 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/10104slr022ltr.pdf
06/04/2003 SUPPL-21 Labeling

Label is not available on this site.
09/28/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
10/27/1998 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
10/27/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
08/03/1998 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/24/1995 SUPPL-16 Labeling

Label is not available on this site.
06/24/1994 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
06/28/1991 SUPPL-14 Labeling

Label is not available on this site.
08/19/1986 SUPPL-13 Labeling

Label is not available on this site.
01/13/1986 SUPPL-11 Labeling

Label is not available on this site.
05/08/1986 SUPPL-10 Labeling

Label is not available on this site.
06/17/1981 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/07/1980 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.
09/18/1979 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
06/28/1979 SUPPL-6 Labeling

Label is not available on this site.
08/18/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/19/2021 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/010104s031lbl.pdf
01/21/2010 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010104s028lbl.pdf
12/09/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf
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