اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20375s021ltr.pdf |
|
01/22/2004 | SUPPL-20 | Labeling |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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) |
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 |
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) |
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) |
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 |
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.
نظرات کاربران