Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 019369
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEGISON ETRETINATE 10MG CAPSULE;ORAL Discontinued None No No
TEGISON ETRETINATE 25MG 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
09/30/1986 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019369Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/16/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

01/12/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/08/1991 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1990 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/05/1988 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/25/1988 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/27/1988 SUPPL-3 Labeling

Label is not available on this site.

04/02/1987 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/29/1987 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