Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050786
Company: ALLERGAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYLERA BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE 140MG;125MG;125MG CAPSULE;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
09/28/2006 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050786s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050786s000_PyleraTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/05/2018 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050786s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050786Orig1s019ltr.pdf
01/25/2018 SUPPL-17 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050786s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050786Orig1s017ltr.pdf
05/30/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050786s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050786Orig1s016ltr.pdf
01/19/2017 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

02/26/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/25/2017 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050786s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050786Orig1s012ltr.pdf
02/05/2014 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/28/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/14/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/05/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/23/2013 SUPPL-7 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050786s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050786Orig1s007ltr.pdf
01/19/2011 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050786s003ltr.pdf
05/24/2007 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050786s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/05/2018 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050786s019lbl.pdf
01/25/2018 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050786s017lbl.pdf
01/25/2018 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050786s017lbl.pdf
05/30/2017 SUPPL-16 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050786s016lbl.pdf
01/25/2017 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050786s012lbl.pdf
01/23/2013 SUPPL-7 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050786s007lbl.pdf
01/23/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050786s007lbl.pdf
05/24/2007 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf
05/24/2007 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf

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