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FDA NDA · NDA021546

REBETOL

Sponsor: SCHERING

APPLICATION
NDA021546
TYPE
NDA
ORIGINAL APPROVAL
2003-07-29
LATEST ACTION
2022-03-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

REBETOL · ReferenceDiscontinued
RIBAVIRIN 40MG/ML · SOLUTION · ORAL

Approval history

2022-03-16Labeling · Supplement 13 · standard — Letter ↗AP
2020-01-28Labeling · Supplement 12 · standard — Letter ↗AP
2019-05-02Labeling · Supplement 11 · standard — Label ↗AP
2015-05-21Labeling · Supplement 9 · standard — Label ↗AP
2013-11-15Labeling · Supplement 8 · standard — Letter ↗AP
2013-09-25Manufacturing (CMC) · Supplement 5 · priorityAP
2013-05-31Labeling · Supplement 7 · standard — Letter ↗AP
2013-02-06Labeling · Supplement 6 · 901 required — Letter ↗AP
2011-05-06REMS · Supplement 4 — Letter ↗AP
2010-10-28REMS · Supplement 2 — Label ↗AP
2009-11-06Labeling · Supplement 1 · unknown — Label ↗AP
2003-07-29Type 3 - New Dosage Form · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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