An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 006188
Company: DAVA PHARMS INC

Medication Guide

Products on NDA 006188

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 006188

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.

Labels for NDA 006188

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

Therapeutic Equivalents for NDA 006188

PROPYLTHIOURACIL

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET;ORAL	Prescription	Yes	AB	006188	DAVA PHARMS INC
PROPYLTHIOURACIL	PROPYLTHIOURACIL	50MG	TABLET;ORAL	Prescription	No	AB	208867	MACLEODS PHARMS LTD

Top