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FDA ANDA · ANDA204703

VALTYA 1/35

ethynodiol diacetate and ethinyl estradiol

Sponsor: XIROMED

APPLICATION
ANDA204703
TYPE
ANDA
ORIGINAL APPROVAL
2016-07-28
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOLPrescription
ETHINYL ESTRADIOL 0.035MG, ETHYNODIOL DIACETATE 1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 4 · standardAP
2017-08-09Labeling · Supplement 1 · standardAP
2016-07-28UNKNOWN · OriginalAP
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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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