Details for New Drug Application (NDA): 205641
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The generic ingredient in ASMANEX HFA is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.
Summary for 205641
Tradename: | ASMANEX HFA |
Applicant: | Organon Llc |
Ingredient: | mometasone furoate |
Patents: | 0 |
Pharmacology for NDA: 205641
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 205641
Suppliers and Packaging for NDA: 205641
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641 | NDA | Organon LLC | 78206-111 | 78206-111-01 | 1 CANISTER in 1 CARTON (78206-111-01) / 120 AEROSOL in 1 CANISTER |
ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641 | NDA | Organon LLC | 78206-111 | 78206-111-59 | 1 CANISTER in 1 CARTON (78206-111-59) / 120 AEROSOL in 1 CANISTER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.10MG/INH | ||||
Approval Date: | Apr 25, 2014 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.20MG/INH | ||||
Approval Date: | Apr 25, 2014 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.05MG/INH | ||||
Approval Date: | Aug 12, 2019 | TE: | RLD: | Yes |
Expired US Patents for NDA 205641
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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