Details for New Drug Application (NDA): 091588
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The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-five drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 091588
Tradename: | MONTELUKAST SODIUM |
Applicant: | Strides Pharma |
Ingredient: | montelukast sodium |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Aug 3, 2012 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Aug 3, 2012 | TE: | RLD: | No |
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