Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062654
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROCEPHIN CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
ROCEPHIN CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
ROCEPHIN CEFTRIAXONE SODIUM EQ 2GM 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
04/30/1987 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
07/30/2004 SUPPL-26 Labeling

Label is not available on this site.

07/26/2004 SUPPL-24 Labeling

Label is not available on this site.

04/28/2004 SUPPL-23 Labeling

Label is not available on this site.

08/13/2002 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/22/2001 SUPPL-18 Labeling

Label is not available on this site.

12/20/1999 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/18/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/04/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/14/1994 SUPPL-14 Labeling

Label is not available on this site.

02/23/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/15/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/23/1993 SUPPL-10 Labeling

Label is not available on this site.

04/02/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/24/1995 SUPPL-8 Labeling

Label is not available on this site.

08/31/1992 SUPPL-7 Labeling

Label is not available on this site.

02/28/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/22/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/01/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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