Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 062291
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE 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
07/30/1980 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2009 SUPPL-30 Labeling-Patient Package Insert

Label is not available on this site.

09/09/2005 SUPPL-26 Labeling

Label is not available on this site.

10/20/1998 SUPPL-25 Labeling

Label is not available on this site.

08/25/1998 SUPPL-24 Labeling

Label is not available on this site.

12/11/1997 SUPPL-23 Labeling

Label is not available on this site.

11/03/1997 SUPPL-22 Labeling

Label is not available on this site.

12/29/1994 SUPPL-21 Labeling

Label is not available on this site.

05/18/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/09/1991 SUPPL-15 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