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FLUOROMETHOLONE

ANDA

FLUOROMETHOLONE | A218819 | SANDOZ INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FML(TE code: AB)

API Supply Chain4 active DMFs3 inactive

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

EUROAPI FRANCEFLUOROMETHOLONE

DMF 44231982

FARMABIOS SPAFLUOROMETHOLONE

DMF 357802021

CURIA SPAIN SAUFLUOROMETHOLONE MICRONIZED

DMF 367722022

HENAN LIHUA PHARMACEUTICAL CO LTDFLUOROMETHOLONE

DMF 376742023

PHARMACIA AND UPJOHNInactiveFLUOROMETHOLONE MICRONIZED

DMF 15411970

ANTIBIOTICOS SPAInactiveFLUOROMETHOLONE 17-ACETATE NON-MICRONIZED AND MICRONIZED

DMF 37861980

SICOR SPAInactiveFLUOROMETHOLONE

DMF 47611982

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

Products (1)

#001 — 0.1%

0 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Feb 12, 2026

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Sandoz acquired NDA 218819 for fluorometholone ophthalmic suspension from Difgen Pharms.

Old: DIFGEN PHARMS

New: SANDOZ

MODIFIEDApplicant Full Name7/1/2026

Sandoz Inc replaced Difgen Pharmaceuticals LLC as the applicant for fluorometholone NDA 218819-001.

Old: DIFGEN PHARMACEUTICALS LLC

New: SANDOZ INC