Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020375
Company: BAYER HLTHCARE
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 |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-50 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020375s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020375Orig1s049, s050ltr.pdf | |
| 02/15/2024 | SUPPL-49 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020375s049s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020375Orig1s049, s050ltr.pdf | |
| 09/16/2021 | SUPPL-46 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375Orig1s045,s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020375Orig1s045,s046ltr.pdf | |
| 09/16/2021 | SUPPL-45 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375Orig1s045,s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020375Orig1s045,s046ltr.pdf | |
| 09/30/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020375Orig1s036s037ltr.pdf | |
| 09/30/2021 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020375Orig1s036s037ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-50 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020375s049s050lbl.pdf | |
| 02/15/2024 | SUPPL-49 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020375s049s050lbl.pdf | |
| 09/30/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375s036s037lbl.pdf | |
| 09/30/2021 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375s036s037lbl.pdf | |
| 09/16/2021 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375Orig1s045,s046lbl.pdf | |
| 09/16/2021 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020375Orig1s045,s046lbl.pdf | |
| 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.