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SPARINE

NDA

PROMAZINE HYDROCHLORIDE | N010349 | HIKMA PHARMACEUTICALS USA INC

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 Chain0 active DMFs3 inactive

0 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

PCR INCInactivePROMAZINE HYDROCHLORIDE

DMF 22821974

MAY AND BAKER LTDInactivePROMAZINE HYDROCHLORIDE

DMF 61571985

RHONE POULENC RORER INCInactivePROMAZINE HYDROCHLORIDE

DMF 89421991

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

Products (2)

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#006 — 50MG/ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#008 — 25MG/ML

0 patents0 exclusivities▾

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