Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020006
Company: B BRAUN
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MANNITOL 10% IN PLASTIC CONTAINER | MANNITOL | 10GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MANNITOL 15% IN PLASTIC CONTAINER | MANNITOL | 15GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MANNITOL 20% IN PLASTIC CONTAINER | MANNITOL | 20GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| MANNITOL 5% IN PLASTIC CONTAINER | MANNITOL | 5GM/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/24/2019 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020006s028lbl.pdf | |
| 01/09/2019 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020006s025lbl.pdf |