Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203797
Company: HOSPIRA INC
Company: HOSPIRA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DAPTOMYCIN | DAPTOMYCIN | 350MG/VIAL | POWDER;INTRAVENOUS | None (Tentative Approval) | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/15/2013 | ORIG-1 | Tentative Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203797Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203797Orig1s000TAltr.pdf |