Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 016269
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MANNITOL 10% | MANNITOL | 10GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 15% | MANNITOL | 15GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 20% | MANNITOL | 20GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 25% | MANNITOL | 12.5GM/50ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MANNITOL 25% | MANNITOL | 12.5GM/50ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MANNITOL 5% | MANNITOL | 5GM/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/17/2020 | SUPPL-56 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016269s056lbl.pdf | |
| 03/17/2020 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/016269s056lbl.pdf | |
| 01/09/2019 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/016269s055lbl.pdf |