Details for New Drug Application (NDA): 203438
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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 203438
Tradename: | MONTELUKAST SODIUM |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | montelukast sodium |
Patents: | 0 |
Pharmacology for NDA: 203438
Mechanism of Action | Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 203438
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MONTELUKAST SODIUM | montelukast sodium | GRANULE;ORAL | 203438 | ANDA | Ajanta Pharma USA Inc. | 27241-015 | 27241-015-31 | 30 GRANULE in 1 CARTON (27241-015-31) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 4MG BASE/PACKET | ||||
Approval Date: | Jul 31, 2015 | TE: | AB | RLD: | No |
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