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FDA ANDA · ANDA214293

ESTRADIOL AND PROGESTERONE

Sponsor: AMNEAL PHARMS

APPLICATION
ANDA214293
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-16
LATEST ACTION
2025-09-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ESTRADIOL AND PROGESTERONEDiscontinued
ESTRADIOL 1MG, PROGESTERONE 100MG · CAPSULE · ORAL

Approval history

2025-09-28Labeling · Supplement 1 · standardAP
2022-05-16UNKNOWN · Original · standardLetterAP
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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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