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ORAVERSE

NDA

PHENTOLAMINE MESYLATE | N022159 | SEPTODONT HOLDING SAS

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 DMFs1 inactive

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

JIANGSU LIANHUAN PHARMACEUTICAL CO LTDPHENTOLAMINE MESYLATE

DMF 395782024

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)PHENTOLAMINE MESYLATE USP

DMF 399482024

MATRIX PHARMACORP PRIVATE LTDPHENTOLAMINE MESYLATE USP (PROCESS II)

DMF 421122025

SYNKEM DIV PLASTO SAInactivePHENTOLAMINE MESYLATE

DMF 119361996

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 23, 2016	SUPPL -11	View Letter (PDF)
May 14, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.4MG/1.7ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 9, 2008

No patent or exclusivity listings for this strength.