Details for New Drug Application (NDA): 202096
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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 202096
Tradename: | MONTELUKAST SODIUM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | montelukast sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202096
Mechanism of Action | Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 202096
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 202096 | ANDA | RPK Pharmaceuticals, Inc. | 53002-4730 | 53002-4730-1 | 30 TABLET, CHEWABLE in 1 BOTTLE (53002-4730-1) |
MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 202096 | ANDA | Rising Pharma Holdings, Inc. | 57237-212 | 57237-212-30 | 30 TABLET, CHEWABLE in 1 BOTTLE (57237-212-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Aug 3, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Aug 3, 2012 | TE: | AB | RLD: | No |
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