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DECLOMYCIN

NDA

DEMECLOCYCLINE HYDROCHLORIDE | N050257 | LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

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 Chain2 active DMFs7 inactive

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

MYTHEN SPADEMECLOCYCLINE HYDROCHLORIDE

DMF 137921998

CKD BIO CORPDEMECLOCYCLINE HYDROCHLORIDE

DMF 137441998

DIASPA TRADE MARK STRIDES ITALIA SRLInactiveDEMECLOCYCLINE HYDROCHLORIDE

DMF 93801991

WYETH PHARMACEUTICALSInactiveDEMECLOCYCLINE HYDROCHLORIDE

DMF 133301998

FERMIC SA DE CVInactiveDEMECLOCYCLINE HYDROCHLORIDE

DMF 134031998

LEDERLE LABORATORIESInactiveDEMECLOCYCLINE HYDROCHLORIDE

DMF 136041998

LEDERLE LABORATORIESInactiveDEMECLOCYCLINE

DMF 136051998

NORTH CHINA PHARMACEUTICAL CO LTDInactiveDEMECLOCYCLINE HYDROCHLORIDE

DMF 176152004

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveDEMECLOCYCLINE HYDROCHLORIDE USP

DMF 260492012

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

Products (1)

#001 — 75MG/5ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.