Orange Book product · Generic (ANDA)
TYDEMY
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
At a glance
Dec 12, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 2017
8 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Strength
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 205948
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; LEVOMEFOLATE CALCIUM
- 2010SAFYRALBrand (NDA)
NDA 022574 · BAYER HLTHCARE
- 2010BEYAZBrand (NDA)
NDA 022532 · BAYER HLTHCARE
- 2018DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUMGeneric (ANDA)
ANDA 205947 · LUPIN
- 2016DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUMGeneric (ANDA)
ANDA 203593 · WATSON LABS INC
- 2016DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUMGeneric (ANDA)
ANDA 203594 · WATSON LABS INC
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.
