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Details for New Drug Application (NDA): 091414
The generic ingredient in MONTELUKAST SODIUM is montelukast sodium. There are thirty-four 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 091414
Tradename: | MONTELUKAST SODIUM |
Applicant: | Sandoz Inc |
Ingredient: | montelukast sodium |
Patents: | 0 |
Therapeutic Class: | Respiratory Tract Agents |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 091414
Mechanism of Action | Leukotriene Receptor Antagonists |
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 | N | 0781-5554-13 |
MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 091414 | ANDA | Sandoz Inc | 0781-5554 | N | 0781-5554-64 |
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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