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FDA NDA · NDA022055

ALTABAX

Sponsor: ALMIRALL

APPLICATION
NDA022055
TYPE
NDA
ORIGINAL APPROVAL
2007-04-12
LATEST ACTION
2019-09-10
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

ALTABAX · ReferenceDiscontinued
RETAPAMULIN 1% · OINTMENT · TOPICAL

Approval history

2019-09-10Labeling · Supplement 7 · standard — Label ↗AP
2014-06-17Manufacturing (CMC) · Supplement 6 · standardAP
2013-08-01Manufacturing (CMC) · Supplement 3 · standardAP
2012-12-21Labeling · Supplement 2 · unknown — Label ↗AP
2010-09-28Labeling · Supplement 4 · standard — Label ↗AP
2007-04-12Type 1 - New Molecular Entity · Original · standard — Pediatric Medical 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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