IVERMECTIN | A204154 | EDENBRIDGE PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Argenta FDA-2026-P-6705 · 4 docket documents Argenta filed a suitability petition requesting FDA confirmation that an abbreviated new drug application pathway is appropriate for a generic formulation of a drug product. The petition seeks regulatory guidance on the acceptability of the proposed ANDA submission strategy for development of a gene | Suitability | 2026-06-11 | Open | Argenta |
Withdrawal of Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-3664 · 7 docket documents Hyman, Phelps & McNamara, P.C. withdrew its Suitability Petition (Docket No. FDA-2026-P-3664) dated April 2, 2026, which had requested permission under 21 C.F.R. § 314.93(b) to submit an Abbreviated New Drug Application for Ivermectin Tablets in 9 mg, 12 mg, and 15 mg strengths. | Suitability | 2026-05-04 | WithdrawnNo FDA response document on docket | Hyman, Phelps & McNamara, P.C. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2.06
per ea
Lowest NADAC/Unit
$2.06
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 42799080601IVERMECTIN 3 MG TABLET | $2.06 | EA | Generic | — | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.