Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 006188
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROPYLTHIOURACIL PROPYLTHIOURACIL 50MG TABLET;ORAL Prescription BD 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
07/28/1947 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/19/2018 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf
01/15/2016 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006188s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/006188Orig1s025ltr.pdf
02/10/2015 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006188s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/006188Orig1s024ltr.pdf
12/19/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/27/2011 SUPPL-22 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf
07/27/2011 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/006188s021,s022ltr.pdf
04/01/2010 SUPPL-20 Labeling-Package Insert, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/006188s020ltr.pdf
10/01/2001 SUPPL-19 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf
10/01/2001 SUPPL-18 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf
03/11/1999 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/26/1996 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/01/1996 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1990 SUPPL-14 Labeling

Label is not available on this site.

12/04/1987 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/15/1986 SUPPL-10 Labeling

Label is not available on this site.

10/31/1980 SUPPL-6 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

10/31/1980 SUPPL-5 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/19/2018 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf
09/19/2018 SUPPL-26 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf
01/15/2016 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/006188s025lbl.pdf
02/10/2015 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/006188s024lbl.pdf
07/27/2011 SUPPL-22 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf
07/27/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/006188s021s022lbl.pdf
04/01/2010 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020lbl.pdf
04/01/2010 SUPPL-20 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/006188s020lbl.pdf
10/01/2001 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf
10/01/2001 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/6188s018s019Lbl.pdf

PROPYLTHIOURACIL

There are no Therapeutic Equivalents.

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