Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087547
Company: ALCON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOPTO CETAPRED PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM 0.25%;10% SUSPENSION;OPHTHALMIC 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
07/21/1981 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/28/2000 SUPPL-22 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/21/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/18/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/18/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/05/1995 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

08/04/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/06/1994 SUPPL-14 Labeling

Label is not available on this site.

06/28/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/13/1993 SUPPL-12 Labeling

Label is not available on this site.

04/28/1993 SUPPL-11 Labeling

Label is not available on this site.

06/04/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/05/1993 SUPPL-9 Labeling

Label is not available on this site.

06/04/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/27/1990 SUPPL-7 Labeling

Label is not available on this site.

10/26/1989 SUPPL-6 Labeling

Label is not available on this site.

04/27/1989 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/10/1984 SUPPL-1 Manufacturing (CMC)

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