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DEMECLOCYCLINE HYDROCHLORIDE

ANDA

DEMECLOCYCLINE HYDROCHLORIDE | A065447 | EPIC PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

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

1 letter from Drugs@FDA

Date	Submission	Document
Aug 21, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 150MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 18, 2015

No patent or exclusivity listings for this strength.

#002 — 300MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 18, 2015