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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206685
Company: MYLAN TECHNOLOGIES

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
08/15/2018 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206685Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206685Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2024 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
12/06/2024 SUPPL-4 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/15/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206685Orig1s000Lbl.pdf

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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