Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020950
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DUONEB | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/29/2012 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020950s037lbl.pdf | |
| 03/03/2011 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020950s032lbl.pdf | |
| 03/21/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20950_DuoNeb_prntlbl.pdf |