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CLINDAMYCIN HYDROCHLORIDE

ANDA

CLINDAMYCIN HYDROCHLORIDE | A065061 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CLEOCIN HYDROCHLORIDE(TE code: AB)

API Supply Chain7 active DMFs12 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

CHONGQING CARELIFE PHARMACEUTICAL CO LTDCLINDAMYCIN HYDROCHLORIDE USP, NON STERILE BULK DRUG SUBSTANCE

DMF 137871998

ZYDUS LIFESCIENCES LTDCLINDAMYCIN HYDROCHLORIDE

DMF 192252006

ZHEJIANG TIANTAI PHARMACEUTICAL CO LTDCLINDAMYCIN HYDROCHLORIDE

DMF 204502007

NANYANG PUKANG PHARMACEUTICAL CO LTDCLINDAMYCIN HYDROCHLORIDE

DMF 209712007

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDCLINDAMYCIN HYDROCHLORIDE (PROCESS B)

DMF 272662013

HUBEI YITAI PHARMACEUTICAL CO LTDCLINDAMYCIN HYDROCHLORIDE (NON-STERILE)

DMF 318762017

XINYU PHARMACEUTICAL CO LTDCLINDAMYCIN HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE)

DMF 323422018

AMERICAN CHEMICAL INDUSTRIAL CORPInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 72891988

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORYInactiveCLINDAMYCIN HYDROCHLORIDE ETHANOLATE INTERMEDIATE

DMF 128861998

PFIZER INCInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 133711998

ABBOTT LABORATORIESInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 137021998

SHENZHENInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 137691998

BIOCHIMICA OPOS SPAInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 142601995

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveCLINDAMYCIN HYDROCHLORIDE USP

DMF 145391999

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 168152003

ACS DOBFAR SPAInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 187042005

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORYInactiveCLINDAMYCIN HYDROCHLORIDE

DMF 187782005

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORYInactiveCLINDAMYCIN HYDROCHLORIDE USP

DMF 210832007

AUROBINDO PHARMA LTDInactiveCLINDAMYCIN HYDROCHLORIDE USP

DMF 259012012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 2, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 150MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Feb 2, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 300MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 2, 2001