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FDA ANDA · ANDA074749

ALBUTEROL SULFATE

Sponsor: HIKMA

APPLICATION
ANDA074749
TYPE
ANDA
ORIGINAL APPROVAL
1998-01-30
LATEST ACTION
2017-09-25
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Discontinued

Products

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

Approval history

2017-09-25Manufacturing (CMC) · Supplement 10AP
2001-12-21Manufacturing (CMC) · Supplement 8AP
2001-12-21Manufacturing (CMC) · Supplement 6AP
2001-12-21Manufacturing (CMC) · Supplement 9AP
2001-12-21Manufacturing (CMC) · Supplement 7AP
2001-02-16Labeling · Supplement 5AP
1999-11-04Manufacturing (CMC) · Supplement 4AP
1999-11-04Manufacturing (CMC) · Supplement 2AP
1999-11-04Labeling · Supplement 3AP
1999-11-04Manufacturing (CMC) · Supplement 1AP
1998-01-30OriginalAP
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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