Orange Book product · Brand (NDA)
MIRENA
LEVONORGESTREL
At a glance
Dec 06, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 06, 2000
25 yr 11 mo ago
Today
Patent 11850182 expires
Listed drug product patent expiration.
Sep 14, 2029
in 3 yr 3 mo
Patent 10561524 expires
Listed method-of-use patent (U-2948) expiration.
Sep 16, 2029
in 3 yr 4 mo
Pharmaceutical detail
Active ingredient
LEVONORGESTREL
Strength
52MG
Dosage form
SYSTEM
Route
INTRAUTERINE
TE code
Not listed
Application
NDA 021225
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 1999PLAN BBrand (NDA)
NDA 021045 · FDN CONSUMER
- 1996JADELLEBrand (NDA)
NDA 020544 · POPULATION COUNCIL
- 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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11850182 | Sep 14, 2029 | in 3 yr 3 mo | ProductU-3819 |
| 10561524 | Sep 16, 2029 | in 3 yr 4 mo | U-2948 |
