Orange Book product · Generic (ANDA)
AMABELZ
ESTRADIOL; NORETHINDRONE ACETATE
At a glance
Jun 20, 2016
Approved
Generic (ANDA)
Application
BX
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 20, 2016
10 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Strength
0.5MG;0.1MG
Dosage form
TABLET
Route
ORAL
TE code
BX
Application
ANDA 203339
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ESTRADIOL; NORETHINDRONE ACETATE
- 2006ACTIVELLABrand (NDA)
NDA 020907 · AMNEAL
- 1998COMBIPATCHBrand (NDA)
NDA 020870 · NOVEN PHARMS INC
- 2023ETYQAGeneric (ANDA)
ANDA 214729 · AUROBINDO PHARMA LTD
- 2019ESTRADIOL AND NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 210612 · NOVAST LABS
- 2018ESTRADIOL AND NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 210233 · NAARI PTE
- 2017ESTRADIOL AND NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 207261 · XIROMED
- 2012ESTRADIOL AND NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 200747 · TEVA PHARMS USA
- 2011ESTRADIOL AND NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 078324 · BRECKENRIDGE PHARM
- 2010ESTRADIOL AND NORETHINDRONE ACETATEGeneric (ANDA)
ANDA 079193 · BARR
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.
