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NYSTATIN

ANDA

NYSTATIN | A061966 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs5 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

CENTRIENT PHARMACEUTICALS NETHERLANDS BVNYSTATIN

DMF 135231998

VUAB PHARMA ASNYSTATIN USP

DMF 140561999

ANTIBIOTICE SANYSTATIN

DMF 148132000

CONCORD BIOTECH LTDNYSTATIN USP

DMF 417912025

SHAOXING PHARMACEUTICAL FACTORYInactiveNYSTATIN

DMF 125571997

ER SQUIBB AND SONS INCInactiveNYSTATIN

DMF 132981998

BRISTOL MYERS SQUIBB COInactiveNYSTATIN

DMF 134411998

LEDERLE LABORATORIESInactiveNYSTATIN BULK POWDER

DMF 150282000

OLON SPAInactiveNYSTATIN

DMF 352252020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 100,000 UNITS/GM

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals Inc updated its corporate name to Cosette Pharmaceuticals NC Laboratories LLC for nystatin NDA 061966.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name from "Cosette" to "Cosette Pharms NC" for Nystatin NDA 061966.

Old: COSETTE

New: COSETTE PHARMS NC