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ANCOBON

NDA

FLUCYTOSINE | N017001 | BAUSCH HEALTH US LLC

2 strengths0 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 Chain4 active DMFs2 inactive

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

CALYX CHEMICALS AND PHARMACEUTICALS LTDFLUCYTOSINE

DMF 235032010

NANTONG JINGHUA PHARMACEUTICAL CO LTDFLUCYTOSINE

DMF 250942011

MAITHRI LABORATORIES PRIVATE LTDFLUCYTOSINE USP

DMF 319592017

SOLARA ACTIVE PHARMA SCIENCES LTDFLUCYTOSINE USP

DMF 320902017

HOFFMANN LA ROCHE INCInactiveFLUCYTOSINE CAPSULES AND MATCHING PLACEBO

DMF 92591991

ACETO CORPInactiveFLUCYTOSINE USP

DMF 154762001

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

Approval Letters

7 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 500MG

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982