Details for New Drug Application (NDA): 021730
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NDA 021730 describes XOPENEX HFA, which is a drug marketed by Lupin and is included in one NDA. It is available from five suppliers. Additional details are available on the XOPENEX HFA profile page.
The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the levalbuterol tartrate profile page.
The generic ingredient in XOPENEX HFA is levalbuterol tartrate. There are nine drug master file entries for this compound. Five 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: | 0 |
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 | |||||
Expired US Patents for NDA 021730
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