Details for New Drug Application (NDA): 020833
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NDA 020833 describes FLOVENT DISKUS 50, which is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the FLOVENT DISKUS 50 profile page.
The generic ingredient in FLOVENT DISKUS 50 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 DISKUS 50 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 020833
| Tradename: | FLOVENT DISKUS 50 |
| Applicant: | Glaxo Grp Ltd |
| Ingredient: | fluticasone propionate |
| Patents: | 0 |
Pharmacology for NDA: 020833
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 020833
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLOVENT DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833 | NDA | A-S Medication Solutions | 50090-1245 | 50090-1245-0 | 1 INHALER in 1 CARTON (50090-1245-0) / 60 POWDER, METERED in 1 INHALER |
| FLOVENT DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833 | NDA AUTHORIZED GENERIC | A-S Medication Solutions | 50090-7076 | 50090-7076-0 | 1 INHALER in 1 CARTON (50090-7076-0) / 60 POWDER, METERED in 1 INHALER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.05MG/INH | ||||
| Approval Date: | Sep 29, 2000 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.1MG/INH | ||||
| Approval Date: | Sep 29, 2000 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INHALATION | Strength | 0.25MG/INH | ||||
| Approval Date: | Sep 29, 2000 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020833
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxo Grp Ltd | FLOVENT DISKUS 250 | fluticasone propionate | POWDER;INHALATION | 020833-003 | Sep 29, 2000 | 7,225,808*PED | ⤷ Get Started Free |
| Glaxo Grp Ltd | FLOVENT DISKUS 250 | fluticasone propionate | POWDER;INHALATION | 020833-003 | Sep 29, 2000 | 6,536,427*PED | ⤷ Get Started Free |
| Glaxo Grp Ltd | FLOVENT DISKUS 100 | fluticasone propionate | POWDER;INHALATION | 020833-002 | Sep 29, 2000 | 6,536,427*PED | ⤷ Get Started Free |
| Glaxo Grp Ltd | FLOVENT DISKUS 50 | fluticasone propionate | POWDER;INHALATION | 020833-001 | Sep 29, 2000 | 4,335,121*PED | ⤷ Get Started Free |
| Glaxo Grp Ltd | FLOVENT DISKUS 250 | fluticasone propionate | POWDER;INHALATION | 020833-003 | Sep 29, 2000 | 6,032,666*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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