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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/06/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021746s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021746s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/03/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/2013 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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04/10/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/19/2012 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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 |