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ZIDOVUDINE

NDA

ZIDOVUDINE | N200732 | PHARMOBEDIENT CONSULTING 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

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 Chain9 active DMFs9 inactive

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

CIPLA LTDZIDOVUDINE USP

DMF 166772003

APITORIA PHARMA PRIVATE LTDZIDOVUDINE USP

DMF 176382004

MATRIX PHARMACORP PRIVATE LTDZIDOVUDINE USP (PROCESS-I)

DMF 177512004

HETERO LABS LTDZIDOVUDINE (PROCESS I)

DMF 182912005

APITORIA PHARMA PRIVATE LTDZIDOVUDINE USP

DMF 187142005

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDZIDOVUDINE USP

DMF 212772008

HETERO LABS LTDZIDOVUDINE (PROCESS II)

DMF 246082011

SOLARA ACTIVE PHARMA SCIENCES LTDZIDOVUDINE

DMF 250092011

SHANGHAI SHYNDEC PHARMACEUTICAL HAIMEN CO LTDZIDOVUDINE

DMF 272072013

HOUBA INCInactiveZIDOVUDINE

DMF 97121992

ST PHARM CO LTDInactiveZIDOVUDINE DRUG SUBSTANCE

DMF 131811998

RANBAXY LABORATORIES LTDInactiveZIDOVUDINE USP DRUG SUBSTANCE

DMF 207032007

SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISEInactiveZIDOVUDINE USP

DMF 213252008

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)InactiveZIDOVUDINE USP

DMF 215702008

MYLAN LABORATORIES LTDInactiveZIDOVUDINE USP (PROCESS II)

DMF 244502010

MYLAN LABORATORIES LTDInactiveZIDOVUDINE USP (PROCESS III)

DMF 245502010

MATRIX PHARMA GROUP XIAMEN LTDInactiveZIDOVUDINE USP

DMF 250822011

ZHEJIANG LANGHUA PHARMACEUTICAL CO LTDInactiveZIDOVUDINE (NON-STERILE, BULK FORM)

DMF 266952012

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 30, 2019	SUPPL -2	View Letter (PDF)
Feb 28, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 23, 2011

No patent or exclusivity listings for this strength.