Details for New Drug Application (NDA): 022518
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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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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