Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
| Prescription | 006 |
| Prescription | 007 |
Application Products
| 001 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.05MG/24HR | 1 | CLIMARA | ESTRADIOL |
| 002 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.1MG/24HR | 1 | CLIMARA | ESTRADIOL |
| 003 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.075MG/24HR | 1 | CLIMARA | ESTRADIOL |
| 004 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.025MG/24HR | 1 | CLIMARA | ESTRADIOL |
| 005 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.0375MG/24HR | 1 | CLIMARA | ESTRADIOL |
| 006 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.06MG/24HR | 1 | CLIMARA | ESTRADIOL |
| 007 | FILM, EXTENDED RELEASE;TRANSDERMAL | 0.014MG/24HR | 2 | MENOSTAR | ESTRADIOL |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1994-12-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1995-02-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1995-09-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1995-10-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-05-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 1997-04-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1997-09-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1998-02-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1998-03-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1998-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1999-03-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1998-06-11 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1999-05-20 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2001-04-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 16 | AP | 2001-04-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-09-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2004-01-22 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2005-03-18 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2005-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2005-12-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2007-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2008-01-03 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2013-10-09 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2013-10-10 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2013-05-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2015-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2017-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2017-11-01 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2021-09-30 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2021-09-30 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2021-09-16 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2021-09-16 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 7 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 35 | Null | 15 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 45 | Null | 6 |
| SUPPL | 46 | Null | 6 |
TE Codes
| 001 | Prescription | AB2 |
| 002 | Prescription | AB2 |
| 003 | Prescription | AB2 |
| 004 | Prescription | AB2 |
| 005 | Prescription | AB2 |
| 006 | Prescription | AB |
CDER Filings
cder:Array
(
[0] => Array
(
[ApplNo] => 20375
[companyName] =>
[docInserts] => ["",""]
[products] => []
[labels] =>
[originalApprovals] => []
[supplements] =>
[actionDate] => 0000-00-00
)
)