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GRISEOFULVIN

ANDA

GRISEOFULVIN, MICROSIZE | A065438 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Products (1)

#001 — 125MG/5ML

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Oct 8, 2010

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name from "Cosette" to "Cosette Pharms NC" for griseofulvin microsize NDA 065438.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals Inc updated its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for the Griseofulvin microsize NDA 065438.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC