Orange Book product · Brand (NDA)
SKLICE
IVERMECTIN
At a glance
Feb 07, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 07, 2012
14 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
IVERMECTIN
Strength
0.5%
Dosage form
LOTION
Route
TOPICAL
TE code
Not listed
Application
NDA 202736
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.
- 2014SOOLANTRABrand (NDA)
NDA 206255 · GALDERMA LABS LP
- 1998STROMECTOLBrand (NDA)
NDA 050742 · MERCK SHARP DOHME
- 2026IVERMECTINGeneric (ANDA)
ANDA 218509 · AJANTA PHARMA LTD
- 2026IVERMECTINGeneric (ANDA)
ANDA 216808 · E5 PHARMA
- 2026IVERMECTINGeneric (ANDA)
ANDA 216863 · ZYDUS LIFESCIENCES
- 2025IVERMECTINGeneric (ANDA)
ANDA 218805 · EPIC PHARMA LLC
- 2025IVERMECTINGeneric (ANDA)
ANDA 215922 · RUBICON RESEARCH
- 2024IVERMECTINGeneric (ANDA)
ANDA 218324 · SENORES PHARMS
- 2022IVERMECTINGeneric (ANDA)
ANDA 215210 · ZYDUS LIFESCIENCES
- 2022IVERMECTINGeneric (ANDA)
ANDA 212485 · TEVA PHARMS USA
- 2020IVERMECTINGeneric (ANDA)
ANDA 210720 · TARO
- 2020IVERMECTINGeneric (ANDA)
ANDA 210225 · PADAGIS ISRAEL
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.
