Viewing data from:

DECLOMYCIN

NDA

DEMECLOCYCLINE HYDROCHLORIDE | N050261 | COREPHARMA LLC

3 strengths0 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.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Sep 7, 2012	SUPPL -101	View Letter (PDF)
Apr 25, 2008	SUPPL -100	View Letter (PDF)
Dec 22, 2003	SUPPL -94	View Letter (PDF)
Dec 22, 2003	SUPPL -97	View Letter (PDF)
May 30, 2003	SUPPL -95	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

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

#003 — 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

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