Details for New Drug Application (NDA): 203037
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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 203037
Tradename: | MONTELUKAST SODIUM |
Applicant: | Unimark Remedies Ltd |
Ingredient: | montelukast sodium |
Patents: | 0 |
Pharmacology for NDA: 203037
Mechanism of Action | Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 203037
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 203037 | ANDA | Proficient Rx LP | 63187-626 | 63187-626-30 | 30 TABLET, CHEWABLE in 1 BOTTLE (63187-626-30) |
MONTELUKAST SODIUM | montelukast sodium | TABLET, CHEWABLE;ORAL | 203037 | ANDA | Proficient Rx LP | 63187-626 | 63187-626-60 | 60 TABLET, CHEWABLE in 1 BOTTLE (63187-626-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Oct 30, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Oct 30, 2014 | TE: | AB | RLD: | No |
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