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FDA ANDA · ANDA076130

VOSPIRE ER

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA076130
TYPE
ANDA
ORIGINAL APPROVAL
2002-09-30
LATEST ACTION
2007-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

VOSPIRE ERDiscontinued
ALBUTEROL SULFATE EQ 8MG BASE · TABLET, EXTENDED RELEASE · ORAL
VOSPIRE ERDiscontinued
ALBUTEROL SULFATE EQ 4MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2007-02-09Labeling · Supplement 10AP
2006-08-15Labeling · Supplement 6AP
2004-01-16Labeling · Supplement 2AP
2002-09-30OriginalReviewAP
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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