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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050786
Company: LABS JUVISE

Products on NDA 050786

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYLERA	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	140MG;125MG;125MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050786

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
09/19/2024	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050786s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050786Orig1s027ltr.pdf
07/08/2024	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050786s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/050786Orig1s026ltr.pdf
12/15/2021	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050786s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050786Orig1s025ltr.pdf
03/05/2021	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050786s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050786Orig1s023ltr.pdf
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-Package Insert, Labeling-Container/Carton Labels	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

Labels for NDA 050786

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/19/2024	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050786s027lbl.pdf
07/08/2024	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050786s026lbl.pdf
12/15/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050786s025lbl.pdf
03/05/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050786s023lbl.pdf
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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf
05/24/2007	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050786s001lbl.pdf

Therapeutic Equivalents for NDA 050786

PYLERA

CAPSULE;ORAL; 140MG;125MG;125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	140MG;125MG;125MG	CAPSULE;ORAL	Prescription	No	AB	205770	ENDO OPERATIONS
BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	140MG;125MG;125MG	CAPSULE;ORAL	Prescription	No	AB	217511	NOVAST LABS
PYLERA	BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE	140MG;125MG;125MG	CAPSULE;ORAL	Prescription	Yes	AB	050786	LABS JUVISE

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