Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075182
Company: MYLAN TECHNOLOGIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESTRADIOL ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No No
ESTRADIOL ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No No
ESTRADIOL ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 No No
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
ESTRADIOL ESTRADIOL 0.06MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB No No
ESTRADIOL ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 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
02/24/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75182ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75182_Estradiol.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2014 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

07/09/2009 SUPPL-23 Labeling

Label is not available on this site.

07/20/2006 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75182 s015s016_ltr.pdf
07/20/2006 SUPPL-15 Manufacturing (CMC)-New Strength Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/75182 s015s016_ltr.pdf
10/06/2005 SUPPL-14 Labeling

Label is not available on this site.

01/21/2005 SUPPL-13 Labeling

Label is not available on this site.

01/06/2005 SUPPL-11 Labeling

Label is not available on this site.

01/26/2005 SUPPL-9

Label is not available on this site.

01/26/2005 SUPPL-8 Labeling

Label is not available on this site.

01/26/2005 SUPPL-6

Label is not available on this site.

12/23/2002 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/23/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/25/2001 SUPPL-2 Labeling

Label is not available on this site.

11/20/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

ESTRADIOL

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.1MG/24HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLIMARA ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB2 020375 BAYER HLTHCARE
ESTRADIOL ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 075182 MYLAN TECHNOLOGIES

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.075MG/24HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLIMARA ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB2 020375 BAYER HLTHCARE
ESTRADIOL ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 075182 MYLAN TECHNOLOGIES

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.025MG/24HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLIMARA ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB2 020375 BAYER HLTHCARE
ESTRADIOL ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 075182 MYLAN TECHNOLOGIES

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLIMARA ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 020375 BAYER HLTHCARE
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 075182 MYLAN TECHNOLOGIES
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 206685 MYLAN TECHNOLOGIES
MINIVELLE ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 203752 NOVEN

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.06MG/24HR
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLIMARA ESTRADIOL 0.06MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB 020375 BAYER HLTHCARE
ESTRADIOL ESTRADIOL 0.06MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB 075182 MYLAN TECHNOLOGIES

FILM, EXTENDED RELEASE;TRANSDERMAL; 0.05MG/24HR
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLIMARA ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription Yes AB2 020375 BAYER HLTHCARE
ESTRADIOL ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 075182 MYLAN TECHNOLOGIES

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