← FDA DRUG APPROVALS
FDA ANDA · ANDA202999
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST
Sponsor: DR REDDYS LABS SA
APPLICATION
ANDA202999
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGESTNone (Tentative Approval)
ESTRADIOL VALERATE 1MG, ESTRADIOL VALERATE 2MG, DIENOGEST 2MG · TABLET · ORAL
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGESTNone (Tentative Approval)
ESTRADIOL VALERATE 3MG, ESTRADIOL VALERATE 2MG, DIENOGEST 3MG · TABLET · ORAL
Approval history
2016-03-18UNKNOWN · OriginalTA
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.