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FDA NDA · NDA213004

TALICIA

omeprazole magnesium, amoxicillin and rifabutin

Sponsor: TALICIA HOLDINGS

APPLICATION
NDA213004
TYPE
NDA
ORIGINAL APPROVAL
2019-11-01
LATEST ACTION
2024-05-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

TALICIA · ReferencePrescription
AMOXICILLIN 250MG, OMEPRAZOLE MAGNESIUM EQ 10MG BASE, RIFABUTIN 12.5MG · CAPSULE, DELAYED RELEASE · ORAL

Approval history

2024-05-01Labeling · Supplement 14 · standard — Letter ↗AP
2023-09-08Labeling · Supplement 10 · standard — Letter ↗AP
2023-07-18Labeling · Supplement 12 · standard — Letter ↗AP
2022-03-04Labeling · Supplement 7 · standard — Letter ↗AP
2021-10-01Labeling · Supplement 4 · standard — Label ↗AP
2020-11-27Labeling · Supplement 2 · standard — Label ↗AP
2019-11-01Type 4 - New Combination · Original · priority — Label ↗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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