APPLICATION
ANDA076887
TYPE
ANDA
ORIGINAL APPROVAL
2004-05-26
LATEST ACTION
2014-10-21
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
TERBUTALINE SULFATEPrescription
TERBUTALINE SULFATE 1MG/ML · INJECTABLE · INJECTION
Approval history
2014-10-21Manufacturing (CMC) · Supplement 7AP
2011-04-08Labeling · Supplement 5AP
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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