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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012223
Company: PAI HOLDINGS PHARM

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AQUAMEPHYTON PHYTONADIONE 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
AQUAMEPHYTON PHYTONADIONE 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
06/28/1960 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/23/2018 SUPPL-42 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012223s042lbl.pdf
03/07/2018 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012223s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/012223Orig1s041ltr.pdf
05/25/2017 SUPPL-40 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012223s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012223Orig1s040ltr.pdf
06/04/2003 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/012223Orig1s039Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12223slr039ltr.pdf
02/27/2003 SUPPL-38 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12223slr038ltr.pdf
08/16/2001 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.
05/18/2001 SUPPL-36 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12223S36ltr.pdf
07/14/1998 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.
05/28/1998 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.
01/14/1997 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.
12/06/1996 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.
12/06/1996 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.
06/25/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.
12/05/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
06/08/1995 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/24/1995 SUPPL-27 Labeling

Label is not available on this site.
06/28/1991 SUPPL-26 Labeling

Label is not available on this site.
04/26/1990 SUPPL-25 Labeling

Label is not available on this site.
08/27/1985 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/11/1984 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/18/1982 SUPPL-22 Labeling

Label is not available on this site.
08/19/1986 SUPPL-21 Labeling

Label is not available on this site.
07/14/1981 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/03/1981 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
11/28/1980 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
09/18/1979 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
09/01/1976 SUPPL-16 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
11/23/2018 SUPPL-42 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012223s042lbl.pdf
11/23/2018 SUPPL-42 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012223s042lbl.pdf
03/07/2018 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/012223s041lbl.pdf
05/25/2017 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012223s040lbl.pdf
06/04/2003 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/012223Orig1s039Lbl.pdf
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