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NDA

FLUPHENAZINE HYDROCHLORIDE | N011751 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

5 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 Chain8 active DMFs2 inactive

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

FINE CHEMICALS CORP PTY LTDFLUPHENAZINE HYDROCHLORIDE

DMF 56481984

RAKS PHARMA PVT LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 333712018

MSN LIFE SCIENCES PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 337242019

ENALTEC LABS PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 338852019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFLUPHENAZINE HYDROCHLORIDE

DMF 339492019

ALEMBIC PHARMACEUTICALS LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 353662020

AURORE LIFE SCIENCES PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 356952021

CENTAUR PHARMACEUTICALS PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 363262021

ER SQUIBB AND SONS INCInactiveFLUPHENAZINE HYDROCHLORIDE

DMF 47031982

ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES)InactiveFLUPHENAZINE HYDROCHLORIDE

DMF 67151986

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

Products (5)

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#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#004 — 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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

#005 — 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

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