Viewing data from:

CLEOCIN HYDROCHLORIDE

NDA

CLINDAMYCIN HYDROCHLORIDE | N050162 | PFIZER INC

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 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

17 letters from Drugs@FDA

Date	Submission	Document
Mar 30, 2026	SUPPL -107	View Letter (PDF)
Feb 13, 2026	SUPPL -106	View Letter (PDF)
Jul 30, 2024	SUPPL -105	View Letter (PDF)
May 23, 2022	SUPPL -104	View Letter (PDF)
Mar 10, 2020	SUPPL -102	View Letter (PDF)
Jun 17, 2019	SUPPL -101	View Letter (PDF)
Mar 20, 2018	SUPPL -100	View Letter (PDF)
May 8, 2017	SUPPL -99	View Letter (PDF)
May 8, 2017	SUPPL -98	View Letter (PDF)
Mar 25, 2016	SUPPL -96	View Letter (PDF)
Mar 25, 2016	SUPPL -95	View Letter (PDF)
Jun 27, 2014	SUPPL -93	View Letter (PDF)
Jun 27, 2014	SUPPL -92	View Letter (PDF)
Jun 10, 2011	SUPPL -90	View Letter (PDF)
Jan 21, 2010	SUPPL -85	View Letter (PDF)
Oct 4, 2004	SUPPL -82	View Letter (PDF)
Feb 2, 2004	SUPPL -84	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 75MG BASE

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 150MG BASE

RLDAB

0 patents0 exclusivities▾

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

#003 — EQ 300MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 14, 1988