Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210194
Company: PADAGIS ISRAEL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/22/2018 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2018 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ESTRADIOL

CREAM;VAGINAL; 0.01%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRACE ESTRADIOL 0.01% CREAM;VAGINAL Prescription Yes AB 086069 ALLERGAN
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 209767 ALVOGEN
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 208788 MYLAN
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 210194 PADAGIS ISRAEL
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 212313 PRASCO LABS LLC
ESTRADIOL ESTRADIOL 0.01% CREAM;VAGINAL Prescription No AB 210488 TEVA PHARMS USA

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