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EMADINE

NDA

EMEDASTINE DIFUMARATE | N020706 | NOVARTIS PHARMACEUTICALS CORP

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 Chain1 active DMF

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

SHIRATORI PHARMCEUTICAL CO LTDEMEDASTINE DIFUMARATE

DMF 117591995

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 8, 2003	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Dec 29, 1997

No patent or exclusivity listings for this strength.