Details for New Drug Application (NDA): 021730
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The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
Summary for 021730
Tradename: | XOPENEX HFA |
Applicant: | Lupin |
Ingredient: | levalbuterol tartrate |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021730
Generic Entry Date for 021730*:
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: 021730
Mechanism of Action | Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 021730
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730 | NDA AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0591-2927 | 0591-2927-54 | 1 INHALER in 1 CARTON (0591-2927-54) / 200 AEROSOL, METERED in 1 INHALER |
XOPENEX HFA | levalbuterol tartrate | AEROSOL, METERED;INHALATION | 021730 | NDA | Lupin Pharmaceuticals, Inc. | 27437-056 | 27437-056-01 | 1 INHALER in 1 CARTON (27437-056-01) / 200 AEROSOL, METERED in 1 INHALER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | AEROSOL, METERED;INHALATION | Strength | EQ 0.045MG BASE/INH | ||||
Approval Date: | Mar 11, 2005 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 8, 2024 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS |
Expired US Patents for NDA 021730
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