Details for New Drug Application (NDA): 021433
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NDA 021433 describes FLOVENT HFA, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from four suppliers. There are two patents protecting this drug. Additional details are available on the FLOVENT HFA profile page.
The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.
Summary for 021433
| Tradename: | FLOVENT HFA |
| Applicant: | Glaxo Grp Ltd |
| Ingredient: | fluticasone propionate |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021433
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 021433
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433 | NDA | GlaxoSmithKline LLC | 0173-0718 | 0173-0718-20 | 1 INHALER in 1 CARTON (0173-0718-20) / 120 AEROSOL, METERED in 1 INHALER |
| FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433 | NDA | GlaxoSmithKline LLC | 0173-0719 | 0173-0719-20 | 1 INHALER in 1 CARTON (0173-0719-20) / 120 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.22MG/INH | ||||
| Approval Date: | May 14, 2004 | TE: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Dec 19, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.11MG/INH | ||||
| Approval Date: | May 14, 2004 | TE: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 26, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 021433
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-003 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-001 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
| Glaxo Grp Ltd | FLOVENT HFA | fluticasone propionate | AEROSOL, METERED;INHALATION | 021433-002 | May 14, 2004 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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