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LAMIVUDINE

ANDA

LAMIVUDINE | A090198 | MACLEODS PHARMACEUTICALS LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: EPIVIR(TE code: AB)

API Supply Chain23 active DMFs14 inactive

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

CIPLA LTDLAMIVUDINE USP

DMF 175352004

MATRIX PHARMACORP PRIVATE LTDLAMIVUDINE USP

DMF 177502004

HETERO LABS LTDLAMIVUDINE USP (PROCESS I)

DMF 182522005

APITORIA PHARMA PRIVATE LTDLAMIVUDINE USP

DMF 187132005

LUPIN LTDLAMIVUDINE USP

DMF 212302008

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDLAMIVUDINE USP

DMF 212782008

SIGNA SA DE CVLAMIVUDINE METHANOL SOLVATE USP

DMF 229312009

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDLAMIVUDINE

DMF 229822009

APITORIA PHARMA PRIVATE LTDLAMIVUDINE USP (CRYSTALLINE POLYMORPH FORM I)

DMF 236012010

HETERO LABS LTDLAMIVUDINE USP(PROCESS II)

DMF 246092011

WISDOM PHARMACEUTICAL CO LTDLAMIVUDINE

DMF 267392013

MATRIX PHARMACORP PRIVATE LTDLAMIVUDINE USP (PROCESS-II)

DMF 296132015

LANTECH PHARMACEUTICALS LTDLAMIVUDINE COUPLED ESTER

DMF 317792017

LAURUS LABS LTDLAMIVUDINE USP

DMF 318542017

LAURUS LABS LTDLAMIVUDINE USP (PROCESS 1)

DMF 326332018

VIVIN DRUGS AND PHARMACEUTICALS LTDLAMIVUDINE USP

DMF 338912019

SMS PHARMACEUTICALS LTDLAMIVUDINE USP

DMF 343102019

SV LABS PRIVATE LTDLAMIVUDINE COUPLED ESTER (NON-STERILE DRUG INTERMEDIATE)

DMF 345002021

VANDANA LIFE SCIENCES PRIVATE LTDLAMIVUDINE COUPLED ESTER (NON-STERILE DRUG INTERMEDIATE)

DMF 349502020

STYRAX LIFE SCIENCES PRIVATE LTDLAMIVUDINE USP

DMF 359202021

VIYASH LIFE SCIENCES PRIVATE LTDLAMIVUDINE

DMF 373032023

ARENE LIFE SCIENCES PRIVATE LTDLAMIVUDINE

DMF 391242023

EMNAR PHARMA PRIVATE LTDLAMIVUDINE

DMF 421142025

AUROBINDO PHARMA LTDInactiveLAMIVUDINE USP

DMF 179002004

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLAMIVUDINE USP

DMF 200672006

ANHUI BIOCHEM PHARM CO LTDInactiveLAMIVUDINE

DMF 204682007

RANBAXY LABORATORIES LTDInactiveLAMIVUDINE (FORM I)

DMF 206382007

VITALIFE LABORATORIES (A DIV ARCH PHARMALABS LTD)InactiveLAMIVUDINE USP

DMF 215482008

SIBRA PHARMACEUTICALS LTD AN ARCH ENTERPRISEInactiveLAMIVUDINE USP

DMF 215492008

CIPLA LTDInactiveLAMIVUDINE USP (PROCESS 3)

DMF 217632008

CIPLA LTDInactiveLAMIVUDINE USP (PROCESS 2)

DMF 217642008

RANBAXY LABORATORIES LTDInactiveLAMIVUDINE (DRUG SUBSTANCE INTERMEDIATE)

DMF 233212009

TIANISH LABORATORIES PRIVATE LTDInactiveLAMIVUDINE USP (LVD)

DMF 234312010

SHIJIAZHUANG LONZEAL PHARMACEUTICALS CO LTDInactiveLAMIVUDINE FORM I

DMF 270022013

LUPIN LTDInactiveLAMIVUDINE (PROCESS-B)

DMF 270072013

TIANJIN SEGA PHARMA CO LTDInactiveLAMIVUDINE USP

DMF 272472013

LUPIN LTDInactiveLAMIVUDINE USP

DMF 364012021

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 9, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 150MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 1, 2019

No patent or exclusivity listings for this strength.

#002 — 300MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 1, 2019