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Details for New Drug Application (NDA): 091588

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NDA 091588 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, Sandoz Inc, Torrent Pharms Ltd, Accord Hlthcare, Glenmark Generics, Ajanta Pharma Ltd, Roxane, Unimark Remedies Ltd, Hetero Labs Ltd V, 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 thirty-nine NDAs. It is available from fifty-five suppliers. Additional details are available on the MONTELUKAST SODIUM profile page.

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

Summary for NDA: 091588

Vintage Pharms Llc
montelukast sodium
Therapeutic Class:Respiratory Tract Agents

Pharmacology for NDA: 091588

Suppliers and Packaging for NDA: 091588

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
montelukast sodium
TABLET, CHEWABLE;ORAL 091588 ANDA Qualitest Pharmaceuticals 0603-4653 0603-4653-02 90 TABLET, CHEWABLE in 1 BOTTLE (0603-4653-02)
montelukast sodium
TABLET, CHEWABLE;ORAL 091588 ANDA Qualitest Pharmaceuticals 0603-4653 0603-4653-16 30 TABLET, CHEWABLE in 1 BOTTLE (0603-4653-16)

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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