Drugs@FDA: FDA-Approved Drugs
Company: ONY
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
INFASURF PRESERVATIVE FREE | CALFACTANT | 35MG/ML | SUSPENSION;INTRATRACHEAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
07/01/1998 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20521ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20521_Infasurf.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/09/2015 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
03/09/2015 | SUPPL-28 | Supplement |
Label is not available on this site. |
||
03/11/2014 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
10/18/2013 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
12/23/2013 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
07/01/2011 | SUPPL-24 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020521s024ltr.pdf | |
12/10/2009 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
09/13/2002 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
02/19/2002 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
11/20/2001 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
12/12/2002 | SUPPL-8 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20521scm008ltr.pdf |
04/18/2002 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
04/18/2002 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
05/18/2000 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
02/23/2000 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
10/14/1999 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
03/17/1999 | SUPPL-1 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
07/01/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf | |
07/01/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf |