Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 018121
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CATARASE CHYMOTRYPSIN 150 UNITS/VIAL FOR SOLUTION;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
03/27/1979 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/1987 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/14/1984 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/21/1986 SUPPL-3 Labeling

Label is not available on this site.

04/12/1984 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/20/1987 SUPPL-1 Labeling

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