Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST
ANDATentative Approval
ESTRADIOL VALERATE; ESTRADIOL VALERATE; DIENOGEST | A202999 | DR REDDYS LABS SA
Products (2)
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#001 — 1MG;2MG;2MG
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TABLET;ORAL | TA Date: 2016-03-18 00:00:00
No patent or exclusivity listings for this strength.