Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008578
Company: VYERA PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARAPRIM PYRIMETHAMINE 25MG TABLET;ORAL Prescription None 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
01/23/1953 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008578s020lbl.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/21/2017 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s020lbl.pdf
03/16/2017 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/008578Orig1s019ltr.pdf
11/18/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08578slr016ltr.pdf
10/10/2002 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/8578slr015ltr.pdf
04/08/1998 SUPPL-14 Labeling

Label is not available on this site.

03/25/1997 SUPPL-13 Labeling

Label is not available on this site.

04/08/1998 SUPPL-10 Labeling

Label is not available on this site.

10/17/1988 SUPPL-9 Labeling

Label is not available on this site.

02/20/1987 SUPPL-8 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/21/2017 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s020lbl.pdf
03/16/2017 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/008578s019lbl.pdf
11/18/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/08578slr016_daraprim_lbl.pdf
10/10/2002 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/8578s15lbl.pdf
01/23/1953 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/008578s020lbl.pdf

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