Orange Book product · Generic (ANDA)
ESTRACE
ESTRADIOL
At a glance
Jan 31, 1984
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 31, 1984
43 yr ago
Today
Pharmaceutical detail
Active ingredient
ESTRADIOL
Strength
0.01%
Dosage form
CREAM
Route
VAGINAL
TE code
AB
Application
ANDA 086069
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of ESTRADIOL
- 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.
