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OPTIMINE

NDA

AZATADINE MALEATE | N017601 | SCHERING CORP SUB SCHERING PLOUGH 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 Chain0 active DMFs2 inactive

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

IRISH FHER LABORATORIESInactiveAZATADINE MALEATE

DMF 78591989

FINE CHEMICALS CORPInactiveAZATADINE MALEATE

DMF 85231990

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 4, 2002	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.