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Details for New Drug Application (NDA): 020950
NDA 020950 describes DUONEB, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the DUONEB profile page.
The generic ingredient in DUONEB is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
The generic ingredient in DUONEB is albuterol sulfate; ipratropium bromide. There are thirty-eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the albuterol sulfate; ipratropium bromide profile page.
Summary for 020950
| Tradename: | DUONEB |
| Applicant: | Mylan Speciality Lp |
| Ingredient: | albuterol sulfate; ipratropium bromide |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020950
| Mechanism of Action | Cholinergic Antagonists Adrenergic beta2-Agonists |
Suppliers and Packaging for NDA: 020950
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DUONEB | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 020950 | NDA | Eon Labs, Inc. | 0185-7322 | E | 0185-7322-13 |
| DUONEB | albuterol sulfate; ipratropium bromide | SOLUTION;INHALATION | 020950 | NDA | Eon Labs, Inc. | 0185-7322 | E | 0185-7322-30 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INHALATION | Strength | EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||
| Approval Date: | Mar 21, 2001 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Sign Up | Patent Expiration: | Dec 28, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE BRONCHO DILATOR | ||||||||
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