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FDA ANDA · ANDA075877

TERBUTALINE SULFATE

Sponsor: IMPAX LABS

APPLICATION
ANDA075877
TYPE
ANDA
ORIGINAL APPROVAL
2001-06-26
LATEST ACTION
2011-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TERBUTALINE SULFATEPrescription
TERBUTALINE SULFATE 2.5MG · TABLET · ORAL
TERBUTALINE SULFATEPrescription
TERBUTALINE SULFATE 5MG · TABLET · ORAL

Approval history

2011-04-08Labeling · Supplement 1AP
2001-06-26Original — Other Important Information from FDA ↗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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