Orange Book product · Generic (ANDA)
DROSPIRENONE AND ETHINYL ESTRADIOL
DROSPIRENONE; ETHINYL ESTRADIOL
At a glance
Jan 24, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 24, 2020
6 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Strength
3MG;0.03MG
Dosage form
TABLET
Route
ORAL-28
TE code
AB
Application
ANDA 213034
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DROSPIRENONE; ETHINYL ESTRADIOL
- 2006YAZBrand (NDA)
NDA 021676 · BAYER HLTHCARE
- 2001YASMINBrand (NDA)
NDA 021098 · BAYER HLTHCARE
- 2019KYRAGeneric (ANDA)
ANDA 202318 · SUN PHARM
- 2019DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 211944 · HETERO LABS
- 2019KEMEYAGeneric (ANDA)
ANDA 202138 · SUN PHARM
- 2018DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 210017 · JUBILANT CADISTA
- 2018ZUMANDIMINEGeneric (ANDA)
ANDA 209407 · AUROBINDO PHARMA LTD
- 2018LO-ZUMANDIMINEGeneric (ANDA)
ANDA 209632 · AUROBINDO PHARMA LTD
- 2017DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 209423 · JUBILANT CADISTA
- 2017DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 203291 · PHARMOBEDIENT
- 2016DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 207245 · NAARI PTE
- 2016DROSPIRENONE AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 205876 · APOTEX
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.
