Details for New Drug Application (NDA): 022518
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NDA 022518 describes DULERA, which is a drug marketed by Organon Llc and is included in one NDA. It is available from one supplier. Additional details are available on the DULERA profile page.
The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.
The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.
Summary for 022518
| Tradename: | DULERA |
| Applicant: | Organon Llc |
| Ingredient: | formoterol fumarate; mometasone furoate |
| Patents: | 0 |
Pharmacology for NDA: 022518
| Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 022518
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518 | NDA | Organon LLC | 78206-125 | 78206-125-01 | 1 CANISTER in 1 CARTON (78206-125-01) / 120 AEROSOL in 1 CANISTER |
| DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518 | NDA | Organon LLC | 78206-125 | 78206-125-59 | 1 CANISTER in 1 CARTON (78206-125-59) / 120 AEROSOL in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.005MG/INH;0.1MG/INH | ||||
| Approval Date: | Jun 22, 2010 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.005MG/INH;0.2MG/INH | ||||
| Approval Date: | Jun 22, 2010 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.005MG/INH;0.05MG/INH | ||||
| Approval Date: | Aug 12, 2019 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 022518
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