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FDA ANDA · ANDA090873

CLONIDINE TRANSDERMAL SYSTEM

clonidine

Sponsor: ACTAVIS LABS UT INC

APPLICATION
ANDA090873
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-06
LATEST ACTION
2025-06-17
ROUTE
TRANSDERMAL
DOSAGE FORM
SYSTEM
MARKETING STATUS
Prescription

Products

CLONIDINEPrescription
CLONIDINE 0.3MG/24HR · SYSTEM · TRANSDERMAL
CLONIDINEPrescription
CLONIDINE 0.1MG/24HR · SYSTEM · TRANSDERMAL
CLONIDINEPrescription
CLONIDINE 0.2MG/24HR · SYSTEM · TRANSDERMAL

Approval history

2025-06-17Labeling · Supplement 7 · standardAP
2014-05-06OriginalAP
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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