Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075182
Company: MYLAN TECHNOLOGIES
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 |