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PROLIXIN DECANOATE

NDA

FLUPHENAZINE DECANOATE | N016727 | BRISTOL MYERS SQUIBB CO

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 Chain4 active DMFs6 inactive

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

FINE CHEMICALS CORP PTY LTDFLUPHENAZINE DECANOATE

DMF 60261985

TRIFARMA SPAFLUPHENAZINE DECANOATE

DMF 278112013

GLAND PHARMA LTDFLUPHENAZINE DECANOATE

DMF 338992019

MSN LIFE SCIENCES PRIVATE LTDFLUPHENAZINE DECANOATE USP

DMF 339852019

SWORDS LABORATORIES LTDInactiveFLUPHENAZINE DECANOATE

DMF 19921972

ER SQUIBB AND SONS INCInactiveFLUPHENAZINE DECANOATE INJ.

DMF 23741974

ER SQUIBB AND SONS INCInactiveFLUPHENAZINE DECANOATE AND FLUPHENAZINE ENANTHATE

DMF 40201981

NV ORGANONInactiveFLUPHENAZINE DECANOATE

DMF 64091986

LABOCHIMInactiveFLUPHENAZINE DECANOATE

DMF 65791986

FINE CHEMICALS CORP PTY LTDInactiveFLUPHENAZINE DECANOATE OIL(BMS)

DMF 160972002

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

Products (1)

#001 — 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.