Orange Book product · Brand (NDA)
PLAN B ONE-STEP
LEVONORGESTREL
At a glance
Jul 10, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 10, 2009
17 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
LEVONORGESTREL
Strength
1.5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 021998
Product number
001
Marketing status
OTC
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
- 2000MIRENABrand (NDA)
NDA 021225 · BAYER HLTHCARE
- 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
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.
