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MONTELUKAST SODIUM

ANDA

MONTELUKAST SODIUM | A078723 | TEVA PHARMACEUTICALS USA

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SINGULAIR(TE code: AB)

API Supply Chain25 active DMFs11 inactive

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

DELMAR CHEMICALS INCMONTELUKAST SODIUM THIOL ACID

DMF 162432002

TAPI NL BVMONTELUKAST SODIUM

DMF 198292006

MATRIX PHARMACORP PRIVATE LTDMONTELUKAST SODIUM USP

DMF 204252007

MSN PHARMACHEM PRIVATE LTDMONTELUKAST SODIUM USP [ROUTE CODE - MT"]

DMF 205802007

FORMOSA LABORATORIES INCMONTELUKAST SODIUM

DMF 217022008

MSN PHARMACHEM PRIVATE LTDMONTELUKAST SODIUM USP [ROUTE CODE - "MB"]

DMF 224842009

APOTEX INCMONTELUKAST SODIUM USP

DMF 234952010

LAURUS LABS LTDMONTELUKAST SODIUM USP

DMF 237362010

UNIMARK REMEDIES LTDMONTELUKAST SODIUM (PROCESS B)

DMF 243242010

MOREPEN LABORATORIES LTDMONTELUKAST SODIUM

DMF 244452010

DR REDDYS LABORATORIES LTDMONTELUKAST SODIUM [PROCESS-2]

DMF 245162010

HETERO DRUGS LTDMONTELUKAST SODIUM

DMF 246672011

TORRENT PHARMACEUTICALS LTDMONTELUKAST SODIUM

DMF 247212011

MACLEODS PHARMACEUTICALS LTDMONTELUKAST SODIUM

DMF 251042011

MELODY HEALTHCARE PVT LTDMONTELUKAST SODIUM

DMF 258232011

APITORIA PHARMA PRIVATE LTDMONTELUKAST SODIUM USP (NON-STERILE DRUG SUBSTANCE)

DMF 272342013

CIPLA LTDMONTELUKAST SODIUM USP

DMF 280872014

CHINA GATEWAY PHARMACEUTICAL DEVELOPMENT CO LTDMONTELUKAST SODIUM

DMF 285472014

NENTER AND CO INCMONTELUKAST SODIUM INTERMEDIATE MK5

DMF 305212016

TAPI NL BVMONTELUKAST SODIUM

DMF 314132017

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDMONTELUKAST SODIUM

DMF 323072018

UNICHEM LABORATORIES LTDMONTELUKAST SODIUM USP

DMF 331632018

SHANDONG NEW TIME PHARMACEUTICAL CO LTDMONTELUKAST SODIUM USP

DMF 339732019

ZENFOLD SUSTAINABLE TECHNOLOGIES PRIVATE LTDMONTELUKAST SODIUM USP

DMF 391912023

JIANGSU ALPHA GROUP SHENGJI PHARMACEUTICAL (SUQIAN) CO LTDMONTELUKAST SODIUM INTERMEDIATE (MK-5)

DMF 418202025

DR REDDYS LABORATORIES LTDInactiveMONTELUKAST SODIUM USP

DMF 200352006

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM

DMF 205642007

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM (NI)

DMF 218932008

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM (PROCESS A)

DMF 238372010

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveMONTELUKAST SODIUM USP

DMF 245882011

SINTENOVO SA DE CVInactiveMONTELUKAST SODIUM

DMF 247472011

PHARMACEUTICAL WORKS POLPHARMA SAInactiveMONTELUKAST SODIUM

DMF 250612011

LG LIFE SCIENCES LTDInactiveMONTELUKAST SODIUM

DMF 255462011

NEULAND LABORATORIES LTDInactiveMONTELUKAST SODIUM

DMF 255682011

UNIMARK REMEDIES LTDInactiveMONTELUKAST SODIUM USP (PROCESS-C)

DMF 264392012

MSN PHARMACHEM PRIVATE LTDInactiveMONTELUKAST SODIUM USP [ROUTE CODE - "MK"]

DMF 270412013

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 6, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 4MG BASE

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Aug 3, 2012

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

0 patents0 exclusivities▾

TABLET, CHEWABLE;ORAL | Approved: Aug 3, 2012