Orange Book product · Brand (NDA)
MIRCETTE
DESOGESTREL; ETHINYL ESTRADIOL
At a glance
Apr 22, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 22, 1998
28 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Strength
0.15MG,N/A;0.02MG,0.01MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL-28
TE code
Not listed
Application
NDA 020713
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2000CYCLESSABrand (NDA)
NDA 021090 · ASPEN GLOBAL INC
- 1992ORTHO-CEPTBrand (NDA)
NDA 020301 · JANSSEN PHARMS
- 1992DESOGENBrand (NDA)
NDA 020071 · ORGANON USA INC
- 2026DESOGESTREL AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 219761 · ANNORA PHARMA
- 2025AVERIGeneric (ANDA)
ANDA 218933 · AVION PHARMS
- 2018DESOGESTREL AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 207067 · NAARI PTE
- 2017DESOGESTREL AND ETHINYL ESTRADIOLGeneric (ANDA)
ANDA 209170 · NAARI PTE
- 2017KALLIGAGeneric (ANDA)
ANDA 207081 · AUROBINDO PHARMA
- 2017SIMLIYAGeneric (ANDA)
ANDA 206853 · AUROBINDO PHARMA
- 2016VOLNEAGeneric (ANDA)
ANDA 202689 · XIROMED
- 2015BEKYREEGeneric (ANDA)
ANDA 202226 · LUPIN
- 2015ISIBLOOMGeneric (ANDA)
ANDA 202789 · XIROMED
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.
