Orange Book product · Brand (NDA)
ORTHO-CEPT
DESOGESTREL; ETHINYL ESTRADIOL
At a glance
Dec 14, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 1992
34 yr ago
Today
Pharmaceutical detail
Active ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Strength
0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL-21
TE code
Not listed
Application
NDA 020301
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
- 1998MIRCETTEBrand (NDA)
NDA 020713 · TEVA BRANDED PHARM
- 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.
