Details for New Drug Application (NDA): 202813
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The generic ingredient in QNASL 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 202813
Tradename: | QNASL |
Applicant: | Teva Branded Pharm |
Ingredient: | beclomethasone dipropionate |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202813
Generic Entry Date for 202813*:
Constraining patent/regulatory exclusivity:
Dosage:
AEROSOL, METERED;NASAL |
*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: 202813
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 202813
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813 | NDA | Teva Respiratory, LLC | 59310-406 | 59310-406-06 | 1 INHALER in 1 CARTON (59310-406-06) / 60 AEROSOL, METERED in 1 INHALER |
QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813 | NDA | Teva Respiratory, LLC | 59310-406 | 59310-406-08 | 1 INHALER in 1 CARTON (59310-406-08) / 60 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;NASAL | Strength | 0.08MG/ACTUATION | ||||
Approval Date: | Mar 23, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 21, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 24, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;NASAL | Strength | 0.04MG/ACTUATION | ||||
Approval Date: | Dec 17, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 21, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 202813
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-002 | Dec 17, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-001 | Mar 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-001 | Mar 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | QNASL | beclomethasone dipropionate | AEROSOL, METERED;NASAL | 202813-001 | Mar 23, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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