GRISEOFULVIN, MICROSIZE | A065394 | ACTAVIS MID ATLANTIC LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 6 - Suitability Petition Approval Letter for Griseofulvin ultramic... FDA-2024-P-3090 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 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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