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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091414

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NDA 091414 describes MONTELUKAST SODIUM, which is a drug marketed by Mylan Pharms Inc, Amneal Pharms, Kremers Urban Pharms, Teva Pharms, Dr Reddys Labs Ltd, Apotex Inc, Cspc Ouyi Pharm Co, Perrigo R And D, Sandoz Inc, Torrent Pharms Ltd, Accord Hlthcare, Glenmark Generics, Ajanta Pharma Ltd, West-ward Pharms Int, Unimark Remedies Ltd, Hetero Labs Ltd V, Cipla Ltd, Macleods Pharms Ltd, Aurobindo Pharma Ltd, Vintage Pharms Llc, Anbison Lab Co Ltd, Unichem Labs Ltd, Apotex Corp, and Jubilant Generics, and is included in forty-three NDAs. It is available from fifty-two suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-three drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.

Summary for NDA: 091414

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091414

Suppliers and Packaging for NDA: 091414

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONTELUKAST SODIUM
montelukast sodium
TABLET, CHEWABLE;ORAL 091414 ANDA Sandoz Inc 0781-5554 0781-5554-05 500 TABLET, CHEWABLE in 1 BOTTLE (0781-5554-05)
MONTELUKAST SODIUM
montelukast sodium
TABLET, CHEWABLE;ORAL 091414 ANDA Sandoz Inc 0781-5554 0781-5554-13 10 BLISTER PACK in 1 CARTON (0781-5554-13) > 10 TABLET, CHEWABLE in 1 BLISTER PACK (0781-5554-06)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 4MG BASE
Approval Date:Aug 3, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 5MG BASE
Approval Date:Aug 3, 2012TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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