Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018714
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BILTRICIDE PRAZIQUANTEL 600MG TABLET;ORAL Prescription AB 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
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
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.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

BILTRICIDE

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BILTRICIDE PRAZIQUANTEL 600MG TABLET;ORAL Prescription Yes AB 018714 BAYER HLTHCARE
PRAZIQUANTEL PRAZIQUANTEL 600MG TABLET;ORAL Prescription No AB 208820 PAR PHARM INC

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