Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021746
Company: LEES PHARM HK
Company: LEES PHARM HK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SURFAXIN | LUCINACTANT | 8.5ML | SUSPENSION;INTRATRACHEAL | Discontinued | None | No | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/06/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021746s000lbl.pdf |