Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 010909
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRADON ANISINDIONE 50MG TABLET;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
04/05/1957 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/06/2002 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10909s13ltr.pdf
01/12/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/30/1994 SUPPL-10 Labeling

Label is not available on this site.

04/05/1989 SUPPL-9 Labeling

Label is not available on this site.

08/08/1986 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-7 Labeling

Label is not available on this site.

11/18/1981 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/18/1981 SUPPL-5 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