Details for New Drug Application (NDA): 205641
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NDA 205641 describes ASMANEX HFA, 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 ASMANEX HFA profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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 | |||||
| Regulatory Exclusivity Expiration: | Feb 12, 2023 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 205641
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