Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020949
Company: PHARMOBEDIENT
Company: PHARMOBEDIENT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACCUNEB | ALBUTEROL SULFATE | EQ 0.042% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION | Discontinued | None | Yes | No |
| ACCUNEB | ALBUTEROL SULFATE | EQ 0.021% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;INHALATION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 04/28/2022 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020949Orig1s027lbl.pdf | |
| 04/28/2022 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020949Orig1s027lbl.pdf | |
| 03/02/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf |