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FDA ANDA · ANDA211328

HALOETTE

Sponsor: DR REDDYS LABS SA

APPLICATION
ANDA211328
TYPE
ANDA
ORIGINAL APPROVAL
2022-08-05
LATEST ACTION
2025-01-08
ROUTE
VAGINAL
DOSAGE FORM
RING
MARKETING STATUS
Prescription

Products

HALOETTEPrescription
ETHINYL ESTRADIOL 0.015MG/24HR, ETONOGESTREL 0.12MG/24HR · RING · VAGINAL

Approval history

2025-01-08Labeling · Supplement 1 · standardAP
2022-08-05UNKNOWN · Original · standardAP
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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