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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211396
Company: AMNEAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB3 No No
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB3 No No
ESTRADIOL ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB3 No No
ESTRADIOL ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB3 No No
ESTRADIOL ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB3 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
09/28/2020 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
11/20/2023 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

ESTRADIOL

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.025MG/24HR
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 211396 AMNEAL
ESTRADIOL ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 206685 MYLAN TECHNOLOGIES
MINIVELLE ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB3 203752 NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 211396 AMNEAL
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 206685 MYLAN TECHNOLOGIES
MINIVELLE ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB3 203752 NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.05MG/24HR
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 211396 AMNEAL
ESTRADIOL ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 206685 MYLAN TECHNOLOGIES
MINIVELLE ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB3 203752 NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.075MG/24HR
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 211396 AMNEAL
ESTRADIOL ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 206685 MYLAN TECHNOLOGIES
MINIVELLE ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB3 203752 NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/24HR
TE Code = AB3

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESTRADIOL ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 211396 AMNEAL
ESTRADIOL ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB3 206685 MYLAN TECHNOLOGIES
MINIVELLE ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB3 203752 NOVEN
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