Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070185
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOR-OP FLUOROMETHOLONE 0.1% SUSPENSION/DROPS;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
02/27/1986 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
04/19/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

06/10/1994 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/07/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/07/1994 SUPPL-4 Labeling

Label is not available on this site.

10/20/1992 SUPPL-3 Labeling

Label is not available on this site.

06/20/1988 SUPPL-2 Labeling

Label is not available on this site.

06/10/1986 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