Details for New Drug Application (NDA): 021409
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The generic ingredient in SINGULAIR 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 021409
Tradename: | SINGULAIR |
Applicant: | Organon |
Ingredient: | montelukast sodium |
Patents: | 0 |
Pharmacology for NDA: 021409
Mechanism of Action | Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 021409
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SINGULAIR | montelukast sodium | GRANULE;ORAL | 021409 | NDA | Organon LLC | 78206-171 | 78206-171-01 | 30 PACKET in 1 CARTON (78206-171-01) / 1 GRANULE in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | EQ 4MG BASE/PACKET | ||||
Approval Date: | Jul 26, 2002 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021409
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | SINGULAIR | montelukast sodium | GRANULE;ORAL | 021409-001 | Jul 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Organon | SINGULAIR | montelukast sodium | GRANULE;ORAL | 021409-001 | Jul 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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