Orange Book product · Brand (NDA)
COMBIPATCH
ESTRADIOL; NORETHINDRONE ACETATE
At a glance
Aug 07, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 07, 1998
28 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Strength
0.05MG/24HR;0.25MG/24HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 020870
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2006ACTIVELLABrand (NDA)
NDA 020907 · AMNEAL
- 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
- 2016AMABELZGeneric (ANDA)
ANDA 203339 · LUPIN
- 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.
