Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Biologic License Application (BLA): 020744
Company: CHIESI USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUROSURF PORACTANT ALFA 80MG/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
11/18/1999 ORIG-1 Approval N/A; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/16/2019 SUPPL-40 Supplement

Label is not available on this site.

11/01/2016 SUPPL-33 Supplement

Label is not available on this site.

11/03/2016 SUPPL-32 Supplement

Label is not available on this site.

05/04/2015 SUPPL-30 Supplement

Label is not available on this site.

10/15/2014 SUPPL-29 Supplement

Label is not available on this site.

10/10/2014 SUPPL-28 Supplement

Label is not available on this site.

02/12/2014 SUPPL-27 Supplement

Label is not available on this site.

04/15/2013 SUPPL-26 Supplement

Label is not available on this site.

04/15/2013 SUPPL-25 Supplement

Label is not available on this site.

09/26/2008 SUPPL-19 Supplement

Label is not available on this site.

12/13/2002 SUPPL-9 Supplement

Label is not available on this site.

04/17/2002 SUPPL-8 Supplement

Label is not available on this site.

06/03/2002 SUPPL-6 Supplement

Label is not available on this site.

04/05/2002 SUPPL-5 Supplement

Label is not available on this site.

03/01/2002 SUPPL-4 Supplement

Label is not available on this site.

11/21/2002 SUPPL-3 Supplement

Label is not available on this site.

02/17/2004 SUPPL-2 Supplement

Label is not available on this site.

06/19/2001 SUPPL-1 Supplement

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English