GRISEOFULVIN, MICROSIZE | A065354 | CIPLA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 6 - Suitability Petition Approval Letter for Griseofulvin ultramic... FDA-2024-P-3090 · 11 docket documents The FDA approved a suitability petition for griseofulvin ultramicrosize oral suspension 250 mg/5 mL, allowing applicants to reference an existing NDA as the basis for submitting ANDAs for this formulation. This approval facilitated generic development of this antifungal product by establishing that | Suitability | 2024-07-01 | Partially Denied | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2013-P-0799 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act on behalf of a client requesting that griseofulvin tablets at 187.5 mg and 375 mg strengths be declared suitable for submission as an abbreviated new drug applic | Other | 2013-07-15 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.2471
per ml
Lowest NADAC/Unit
$0.2471
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69097036108GRISEOFULVIN 125 MG/5 ML SUSP | $0.2471 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.