Details for New Drug Application (NDA): 020830
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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 020830
Tradename: | SINGULAIR |
Applicant: | Organon |
Ingredient: | montelukast sodium |
Patents: | 0 |
Pharmacology for NDA: 020830
Mechanism of Action | Leukotriene Receptor Antagonists |
Suppliers and Packaging for NDA: 020830
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830 | NDA | Organon LLC | 78206-170 | 78206-170-01 | 30 TABLET, CHEWABLE in 1 BOTTLE (78206-170-01) |
SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830 | NDA | Organon LLC | 78206-173 | 78206-173-01 | 30 TABLET, CHEWABLE in 1 BOTTLE (78206-173-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Feb 20, 1998 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Mar 3, 2000 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020830
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-002 | Mar 3, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Organon | SINGULAIR | montelukast sodium | TABLET, CHEWABLE;ORAL | 020830-001 | Feb 20, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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