Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020580
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COTAZYM PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) 30,000USP UNITS;8,000USP UNITS;30,000USP UNITS CAPSULE;ORAL 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
12/09/1996 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA 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
10/12/2000 SUPPL-1 Manufacturing (CMC)-Packaging

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