Orange Book product · Brand (NDA)
JADELLE
LEVONORGESTREL
At a glance
Nov 01, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 01, 1996
30 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVONORGESTREL
Strength
75MG/IMPLANT **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
IMPLANT
Route
IMPLANTATION
TE code
Not listed
Application
NDA 020544
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.
- 2016KYLEENABrand (NDA)
NDA 208224 · BAYER HLTHCARE
- 2015LILETTABrand (NDA)
NDA 206229 · MEDICINES360
- 2013SKYLABrand (NDA)
NDA 203159 · BAYER HLTHCARE
- 2009PLAN B ONE-STEPBrand (NDA)
NDA 021998 · FDN CONSUMER
- 2000MIRENABrand (NDA)
NDA 021225 · BAYER HLTHCARE
- 1999PLAN BBrand (NDA)
NDA 021045 · FDN CONSUMER
- 1996LEVONORGESTRELBrand (NDA)
NDA 020627 · WYETH PHARMS INC
- 1990NORPLANTBrand (NDA)
NDA 019897 · POPULATION COUNCIL
- 1990NORPLANT SYSTEM IN PLASTIC CONTAINERBrand (NDA)
NDA 020088 · WYETH PHARMS INC
- 2025LEVONORGESTRELGeneric (ANDA)
ANDA 219102 · ANNORA PHARMA
- 2019LEVONORGESTRELGeneric (ANDA)
ANDA 207660 · NAARI PTE
- 2018LEVONORGESTRELGeneric (ANDA)
ANDA 205329 · 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.
