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Details for New Drug Application (NDA): 020950
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NDA 020950 describes DUONEB, which is a drug marketed by Mylan Speciality Lp and is included in one NDA. 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. Twelve 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. Twelve 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 |
Paragraph IV (Patent) Challenges for 020950
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DUONEB | SOLUTION;INHALATION | albuterol sulfate; ipratropium bromide | 020950 |
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| Strength | EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | ||||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: | Start Trial | Patent Expiration: | Dec 28, 2021 | Product Flag? | Substance Flag? | Delist Request? | |||
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