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 TABLET;ORAL Prescription AB 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
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
03/16/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/21/2010 SUPPL-28 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

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
12/09/2004 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/010104s023lbl.pdf

MEPHYTON

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEPHYTON PHYTONADIONE 5MG TABLET;ORAL Prescription Yes AB 010104 BAUSCH
PHYTONADIONE PHYTONADIONE 5MG TABLET;ORAL Prescription No AB 209373 AMNEAL PHARMS CO
PHYTONADIONE PHYTONADIONE 5MG TABLET;ORAL Prescription No AB 210189 ZYDUS

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