← FDA DRUG APPROVALS

FDA NDA · NDA050786

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

Sponsor: LABS JUVISE

APPLICATION
NDA050786
TYPE
NDA
ORIGINAL APPROVAL
2006-09-28
LATEST ACTION
2025-11-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

PYLERA · ReferencePrescription
BISMUTH SUBCITRATE POTASSIUM 140MG, METRONIDAZOLE 125MG, TETRACYCLINE HYDROCHLORIDE 125MG · CAPSULE · ORAL

Approval history

2025-11-21Labeling · Supplement 30 · standard — Letter ↗AP
2025-03-31Labeling · Supplement 29 · standard — Label ↗AP
2024-09-19Labeling · Supplement 27 · standard — Letter ↗AP
2024-07-08Labeling · Supplement 26 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 25 · standard — Label ↗AP
2021-03-05Labeling · Supplement 23 · standard — Letter ↗AP
2018-10-05Labeling · Supplement 19 · standard — Label ↗AP
2018-01-25Labeling · Supplement 17 · standard — Letter ↗AP
2017-05-30Labeling · Supplement 16 · standard — Label ↗AP
2017-01-25Labeling · Supplement 12 · standard — Label ↗AP
2017-01-19Manufacturing (CMC) · Supplement 15 · standardAP
2016-02-26Manufacturing (CMC) · Supplement 14 · standardAP
2014-05-28Manufacturing (CMC) · Supplement 10 · standardAP
2014-02-05Manufacturing (CMC) · Supplement 11 · standardAP
2013-08-14Manufacturing (CMC) · Supplement 9 · standardAP
2013-08-05Manufacturing (CMC) · Supplement 8 · standardAP
2013-01-23Labeling · Supplement 7 · standard — Label ↗AP
2011-01-19Labeling · Supplement 3 · standard — Letter ↗AP
2007-05-24Manufacturing (CMC) · Supplement 1 — Label ↗AP
2006-09-28Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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