Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 065263
Company: LUPIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION 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
09/12/2006 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
05/27/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

05/27/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

05/27/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

07/02/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/06/2010 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

02/02/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

06/11/2008 SUPPL-3 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