Details for New Drug Application (NDA): 200889
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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-one suppliers are listed for this compound. Additional details are available on the montelukast sodium profile page.
Summary for 200889
Tradename: | MONTELUKAST SODIUM |
Applicant: | Sandoz Inc |
Ingredient: | montelukast sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200889
Mechanism of Action | Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 200889
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MONTELUKAST SODIUM | montelukast sodium | TABLET;ORAL | 200889 | ANDA | Sandoz Inc | 0781-5560 | 0781-5560-13 | 10 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Aug 3, 2012 | TE: | AB | RLD: | No |
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