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DYNABAC

NDA

DIRITHROMYCIN | N050678 | LILLY RESEARCH LABORATORIES

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 DMF1 inactive

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

HUNAN JIUDIAN PHARMACEUTICAL CO LTDDIRITHROMYCIN

DMF 205842007

CHIFENG ARKER PHARMACEUTICAL TECHNOLOGY CO LTDInactiveDIRITHROMYCIN USP, NON-STERILE DRUG SUBSTANCE

DMF 183932005

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 2, 2004	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 250MG

0 patents0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Jun 19, 1995

No patent or exclusivity listings for this strength.