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TENOFOVIR DISOPROXIL FUMARATE

ANDA

TENOFOVIR DISOPROXIL FUMARATE | A091612 | TEVA PHARMACEUTICALS USA

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VIREAD(TE code: AB)

API Supply Chain31 active DMFs8 inactive

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

CIPLA LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 200032006

MATRIX PHARMACORP PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 201082007

APITORIA PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE (NON-STERILE DRUG SUBSTANCE)

DMF 210962007

HETERO LABS LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 215402008

MACLEODS PHARMACEUTICALS LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 247642011

CIPLA LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS B)

DMF 248522011

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 253042011

LUPIN LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 257872012

SOLARA ACTIVE PHARMA SCIENCES LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 260832012

LAURUS LABS LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS-2)

DMF 270872013

CYDMAX INDIA PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE [DRUG SUBSTANCE(NON-STERILE)]

DMF 271432013

MATRIX PHARMACORP PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS-II)

DMF 274562013

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 284602014

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 285072014

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND TECHNOLOGY CO LTDTENOFOVIR DISOPROXIL FUMARATE (DRUG SUBSTANCE)

DMF 288152014

SHANDONG ANHONG PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 303552016

AURISCO PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 307302016

HETERO LABS LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS II)

DMF 310102016

YANCHENG DESANO PHARMACEUTICAL CO LTDTENOFOVIR

DMF 311462016

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 314612017

LAURUS LABS LTDTENOFOVIR DISOPROXIL FUMARATE (PROCESS-3)

DMF 319582017

HUANGSHI FUERTAI PHARMACEUTICAL TECHNOLOGY CO LTDTENOFOVIR

DMF 334062018

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND TECHNOLOGY CO LTDTENOFOVIR

DMF 335492019

CHROMO LABORATORIES INDIA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 353082021

INNOVARE LABS PRIVATE LTDTENOFOVIR (DRUG SUBSTANCE INTERMEDIATE)

DMF 354252020

JIANGSU PUXIN PHARMACEUTICALS CO LTDTENOFOVIR

DMF 354442021

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 356382023

STYRAX PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 359192021

EMCURE PHARMACEUTICALS LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 372732022

VIYASH LIFE SCIENCES PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 373052022

EMNAR PHARMA PRIVATE LTDTENOFOVIR DISOPROXIL FUMARATE

DMF 408432024

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveTENOFOVIR DISOPROXIL FUMARATE DRUG SUBSTANCE

DMF 210982007

EMCURE PHARMACEUTICALS LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 226232009

LAURUS LABS LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 234502010

SEQUENT SCIENTIFIC LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 234752010

UNIMARK REMEDIES LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 263192012

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDInactiveTENOFOVIR

DMF 267672012

JINGMEN SHUAIBANG CHEMICAL SCIENCE AND TECHNOLOGY CO LTDInactiveTENOFOVIR (DRUG SUBSTANCE INTERMEDIATE)

DMF 280692014

TYCHE INDUSTRIES LTDInactiveTENOFOVIR DISOPROXIL FUMARATE

DMF 281462014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 20, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 300MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 18, 2015

No patent or exclusivity listings for this strength.

#002 — 150MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 26, 2018

#003 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 26, 2018

#004 — 250MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 26, 2018