2007 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed in order by date of approval.
| Tradename/ Established Name |
Indication for Use | NDA Number | Applicant | Approval Date |
|---|---|---|---|---|
| Voluven® 6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection (Voluven 500 mL freeflex flexible plastic intravenous solution container) |
Treatment and prophylaxis of hypovolemia | BN070012 | Fresenius Kabi Deutschland GmbH Else-Kroner-Strasse 1 61352 Bad Homburg v.d.H., Germany |
12/27/2007 |