Orange Book product · Brand (NDA)
STROMECTOL
IVERMECTIN
At a glance
Oct 08, 1998
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 08, 1998
28 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
IVERMECTIN
Strength
3MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 050742
Product number
002
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.
- 2014SOOLANTRABrand (NDA)
NDA 206255 · GALDERMA LABS LP
- 2012SKLICEBrand (NDA)
NDA 202736 · ARBOR PHARMS LLC
- 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.
