Orange Book product · Generic (ANDA)
IVERMECTIN
IVERMECTIN
At a glance
Mar 21, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 21, 2022
4 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
IVERMECTIN
Strength
0.5%
Dosage form
LOTION
Route
TOPICAL
TE code
Not listed
Application
ANDA 212485
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IVERMECTIN
- 2014SOOLANTRABrand (NDA)
NDA 206255 · GALDERMA LABS LP
- 2012SKLICEBrand (NDA)
NDA 202736 · ARBOR PHARMS LLC
- 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
- 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.
