Details for New Drug Application (NDA): 207921
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NDA 207921 describes QVAR REDIHALER, which is a drug marketed by Norton Waterford and is included in one NDA. It is available from three suppliers. There are sixteen patents protecting this drug. Additional details are available on the QVAR REDIHALER profile page.
The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.
The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the beclomethasone dipropionate profile page.
Summary for 207921
| Tradename: | QVAR REDIHALER |
| Applicant: | Norton Waterford |
| Ingredient: | beclomethasone dipropionate |
| Patents: | 16 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 207921
Generic Entry Date for 207921*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;INHALATION |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 207921
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 207921
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921 | NDA | A-S Medication Solutions | 50090-3458 | 50090-3458-0 | 1 INHALER in 1 CARTON (50090-3458-0) / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER |
| QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921 | NDA | A-S Medication Solutions | 50090-3459 | 50090-3459-0 | 1 INHALER in 1 CARTON (50090-3459-0) / 1 CANISTER in 1 INHALER / 120 AEROSOL, METERED in 1 CANISTER |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | 0.04MG/INH | ||||
| Approval Date: | Aug 3, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 207921
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-002 | Aug 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-001 | Aug 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
| Norton Waterford | QVAR REDIHALER | beclomethasone dipropionate | AEROSOL, METERED;INHALATION | 207921-001 | Aug 3, 2017 | ⤷ Subscribe | ⤷ Subscribe |
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