Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017535
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORELCO PROBUCOL 250MG TABLET;ORAL Discontinued None No No
LORELCO PROBUCOL 500MG 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
02/01/1977 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/26/1991 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

05/09/1989 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

05/05/1989 SUPPL-43 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/05/1989 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

07/06/1988 SUPPL-41 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/06/1988 SUPPL-40 Labeling

Label is not available on this site.

01/22/1988 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/31/1988 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1986 SUPPL-36 Labeling

Label is not available on this site.

08/02/1984 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1984 SUPPL-31 Labeling

Label is not available on this site.

05/01/1984 SUPPL-30 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/18/1983 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/07/1983 SUPPL-28 Labeling

Label is not available on this site.

12/02/1981 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/22/1981 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/23/1980 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1978 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/12/1979 SUPPL-6 Labeling

Label is not available on this site.

04/12/1979 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