Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020375
Company: BAYER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLIMARA ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 Yes No
CLIMARA ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 Yes Yes
CLIMARA ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 Yes No
CLIMARA ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB2 Yes No
CLIMARA ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
CLIMARA ESTRADIOL 0.06MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription AB Yes No
MENOSTAR ESTRADIOL 0.014MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription None TBD 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
12/22/1994 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/01/2017 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020375Orig1s035ltr.pdf
11/01/2017 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020375Orig1s034ltr.pdf
08/06/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/14/2013 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/10/2013 SUPPL-28 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s028ltr.pdf
10/09/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020375s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020375Orig1s027ltr.pdf
01/03/2008 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020375s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020375s026ltr.pdf
03/28/2007 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

12/28/2005 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020375s023ltr.pdf
06/22/2005 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020375s022ltr.pdf
03/18/2005 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20375s021ltr.pdf
01/22/2004 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20375slr020ltr.pdf
12/19/2002 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

09/13/2002 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/05/2001 SUPPL-16 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S16ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-375s016_Berlex.cfm
04/04/2001 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375S14lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20375S14ltr.pdf
05/20/1999 SUPPL-13 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20375-s013_climara.pdf
06/11/1998 SUPPL-12 Manufacturing (CMC)-Expiration Date Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s12_climara.cfm
03/05/1999 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994.cfm
06/11/1998 SUPPL-10 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s10_climara.cfm
03/23/1998 SUPPL-9 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara.cfm
02/27/1998 SUPPL-8 Manufacturing (CMC)-Formulation Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020375s8_climara.cfm
09/16/1997 SUPPL-7 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020375-S7_Climara_toc.cfm
04/11/1997 SUPPL-6 Efficacy-New Route Of Administration

Label is not available on this site.

05/17/1996 SUPPL-5 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020375-S5_Climara_toc.cfm
10/10/1995 SUPPL-4 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S4_Climara_toc.cfm
09/22/1995 SUPPL-3 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S3_Climara_toc.cfm
02/28/1995 SUPPL-2 Manufacturing (CMC) Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S2_Climara_toc.cfm
04/25/1995 SUPPL-1 Manufacturing (CMC)-Control Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020375-S1_Climara_toc.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/01/2017 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s035lbl.pdf
11/01/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020375s034lbl.pdf
10/09/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020375s027lbl.pdf
01/03/2008 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020375s026lbl.pdf
12/28/2005 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020375s023LBL.pdf
06/22/2005 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020375s022lbl.pdf
01/22/2004 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020375S020lbl.pdf
04/05/2001 SUPPL-16 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375s16lbl.pdf
04/04/2001 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20375S14lbl.pdf
03/05/1999 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020994_appltr_prntlbl.pdf
03/23/1998 SUPPL-9 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20375s009_Climara_prntlbl.pdf

CLIMARA

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

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

MENOSTAR

There are no Therapeutic Equivalents.

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