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LOCORTEN

NDA

FLUMETHASONE PIVALATE | N016379 | NOVARTIS PHARMACEUTICALS CORP

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs5 inactive

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

FARMABIOS SPAFLUMETHASONE

DMF 155342001

AURISCO PHARMACEUTICAL CO LTDFLUMETHASONE

DMF 198582006

SYMBIOTEC PHARMALAB PRIVATE LTDFLUMETHASONE

DMF 255472011

SYNTEX SAInactiveFLUMETHASONE

DMF 7891964

SYNTEX SAInactiveFLUMETHASONE

DMF 8671964

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveFLUMETHASONE PIVALATE

DMF 89231991

PFIZER INCInactiveFLUMETHASONE

DMF 155592001

HOVIONE FARMACIENCIA SAInactiveFLUMETHASONE

DMF 199812006

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

Products (1)

#001 — 0.03%

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.