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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018714
Company: BAYER HLTHCARE

Products on NDA 018714

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BILTRICIDE	PRAZIQUANTEL	600MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/29/1982	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2023	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018714s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/018714Orig1s020ltr.pdf
01/08/2019	SUPPL-18	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018714s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/018714Orig1s018ltr.pdf
11/20/2014	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/18/2014	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/25/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018714Orig1s013ltr.pdf
08/16/2010	SUPPL-12	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018714s012ltr.pdf
07/14/2004	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf
07/14/2004	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18714s008,009ltr.pdf
11/07/1989	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1988	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/09/1988	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1988	SUPPL-3	Labeling		Label is not available on this site.
08/20/1985	SUPPL-2	Labeling		Label is not available on this site.
05/11/1983	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 018714

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018714s020lbl.pdf
01/08/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018714s018lbl.pdf
01/08/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018714s018lbl.pdf
02/25/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018714s013lbl.pdf
08/16/2010	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018714s012lbl.pdf
07/14/2004	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf
07/14/2004	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18714s008,009lbl.pdf

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