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NDA

CLINDAMYCIN PHOSPHATE | N050801 | NORVIUM BIOSCIENCE LLC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Delcor Asset Corporation et al v. Glenmark Pharmaceuticals Limited et al 1:2017cv01653 2 patentsANDA 210778clindamycin phosphate	D. Del.	2017-11-15	Terminated 2019-03-05	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain11 active DMFs14 inactive

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

TRIFARMA SPACLINDAMYCIN PHOSPHATE USP

DMF 129221998

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE U.S.P.

DMF 130821998

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCCLINDAMYCIN PHOSPHATE USP, KALAMAZOO

DMF 134131998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)CLINDAMYCIN PHOSPHATE USP

DMF 144121999

CHONGQING CARELIFE PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE USP

DMF 163572003

ZHEJIANG TIANTAI PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE

DMF 174222004

ACS DOBFAR SPACLINDAMYCIN PHOSPHATE

DMF 187052005

XINYU PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE USP

DMF 243582010

ZYDUS LIFESCIENCES LTDCLINDAMYCIN PHOSPHATE USP

DMF 266692015

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE (PROCESS B)

DMF 272712013

HUBEI YITAI PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE (NON-STERILE)

DMF 322552017

DELMAR CHEMICALS INCInactiveCLINDAMYCIN PHOSPHATE

DMF 71931987

AMERICAN CHEMICAL INDUSTRIAL CORPInactiveCLINDAMYCIN PHOSPHATE

DMF 73591988

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveCLINDAMYCIN PHOSPHATE USP

DMF 134991998

ABBVIE INCInactiveCLINDAMYCIN PHOSPHATE

DMF 137031998

ROUSSELL UCLAFInactiveCLINDAMYCIN PHOSPHATE

DMF 137051998

GENZYME CORPInactiveCLINDAMYCIN PHOSPHATE

DMF 137251998

DELMAR CHEMICALS INCInactiveCLINDAMYCIN PHOSPHATE

DMF 137291998

ZHEJIANG TAIZHOU HISOAR PHARM CHEM CO LTDInactiveCLINDAMYCIN PHOSPHATE

DMF 147972000

DSM PHARMACEUTICALS INCInactiveCLINDAMYCIN PHOSPHATE

DMF 152902001

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORYInactiveCLINDAMYCIN PHOSPHATE USP

DMF 162252002

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN PHOSPHATE USP

DMF 170522003

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveCLINDAMYCIN PHOSPHATE USP (AR)

DMF 185332005

ZHEJIANG WEPON PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN PHOSPHATE

DMF 197412006

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN PHOSPHATE

DMF 209372007

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 20, 2018	SUPPL -18	View Letter (PDF)
Jan 25, 2012	SUPPL -15	View Letter (PDF)
Dec 22, 2010	SUPPL -11	View Letter (PDF)
Jul 13, 2006	SUPPL -6	View Letter (PDF)
Oct 22, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Oct 22, 2004

No patent or exclusivity listings for this strength.