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FDA ANDA · ANDA074454

ALBUTEROL SULFATE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA074454
TYPE
ANDA
ORIGINAL APPROVAL
1995-09-25
LATEST ACTION
2015-06-10
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

ALBUTEROL SULFATEDiscontinued
ALBUTEROL SULFATE EQ 2MG BASE/5ML · SYRUP · ORAL

Approval history

2015-06-10Labeling · Supplement 30AP
2002-12-03Manufacturing (CMC) · Supplement 11AP
2001-05-18Manufacturing (CMC) · Supplement 10AP
2000-10-16Manufacturing (CMC) · Supplement 8AP
1999-07-13Labeling · Supplement 6AP
1999-07-07Manufacturing (CMC) · Supplement 5AP
1999-07-07Manufacturing (CMC) · Supplement 3AP
1999-07-07Labeling · Supplement 4AP
1999-01-12Labeling · Supplement 2AP
1995-09-25OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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