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CLIMARA از شرکت BAYER HLTHCARE

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CLIMARA از شرکت BAYER HLTHCARE

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

AB2

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 = AB2

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 AB2 020375 BAYER HLTHCARE
ESTRADIOL ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Prescription No AB2 075182 MYLAN TECHNOLOGIES

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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