Orange Book product · Brand (NDA)
ESTRADERM
ESTRADIOL
At a glance
Sep 10, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 1986
40 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ESTRADIOL
Strength
0.05MG/24HR
Dosage form
SYSTEM
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 019081
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2018IMVEXXYBrand (NDA)
NDA 208564 · MAYNE PHARMA
- 2014MINIVELLEBrand (NDA)
NDA 203752 · NOVEN
- 2007EVAMISTBrand (NDA)
NDA 022014 · PADAGIS US
- 2007DIVIGELBrand (NDA)
NDA 022038 · VERTICAL PHARMS
- 2006ELESTRINBrand (NDA)
NDA 021813 · VIATRIS
- 2004MENOSTARBrand (NDA)
NDA 021674 · BAYER HLTHCARE
- 2004ESTROGELBrand (NDA)
NDA 021166 · ASCEND THERAPS US
- 2002VIVELLE-DOTBrand (NDA)
NDA 020538 · SANDOZ
- 2002ALORABrand (NDA)
NDA 020655 · ABBVIE
- 2000VIVELLEBrand (NDA)
NDA 020323 · SANDOZ
- 1999ESTRADIOLBrand (NDA)
NDA 021048 · ORTHO MCNEIL PHARM
- 1999CLIMARABrand (NDA)
NDA 020375 · BAYER HLTHCARE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
