Drugs@FDA: FDA-Approved Drugs
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 | AB2 | 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 = 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 |
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 |