Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050504
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MANDOL CEFAMANDOLE NAFATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
MANDOL CEFAMANDOLE NAFATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
MANDOL CEFAMANDOLE NAFATE EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
MANDOL CEFAMANDOLE NAFATE 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
09/27/1978 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
05/22/2002 SUPPL-64 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/2003 SUPPL-62 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50504slr062ltr.pdf
01/05/1999 SUPPL-61 Manufacturing (CMC)

Label is not available on this site.

06/18/1996 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

07/18/2002 SUPPL-59 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50504s059ltr.pdf
03/23/1993 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

12/31/1992 SUPPL-57 Labeling

Label is not available on this site.

11/16/1981 SUPPL-55 Labeling

Label is not available on this site.

09/04/1981 SUPPL-54 Labeling

Label is not available on this site.

02/11/1981 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

11/23/1980 SUPPL-52 Labeling

Label is not available on this site.

11/20/1980 SUPPL-51 Labeling

Label is not available on this site.

11/20/1980 SUPPL-50 Labeling

Label is not available on this site.

11/20/1980 SUPPL-49 Labeling

Label is not available on this site.

11/20/1980 SUPPL-48 Labeling

Label is not available on this site.

10/28/1980 SUPPL-47 Labeling

Label is not available on this site.

10/03/1980 SUPPL-46 Labeling

Label is not available on this site.

07/01/1980 SUPPL-45 Labeling

Label is not available on this site.

06/17/1980 SUPPL-44 Labeling

Label is not available on this site.

05/28/1980 SUPPL-43 Labeling

Label is not available on this site.

05/01/1980 SUPPL-42 Labeling

Label is not available on this site.

05/01/1980 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1980 SUPPL-40 Labeling

Label is not available on this site.

11/13/1979 SUPPL-39 Labeling

Label is not available on this site.

09/10/1979 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1979 SUPPL-37 Labeling

Label is not available on this site.

05/15/1979 SUPPL-36 Labeling

Label is not available on this site.

08/01/1979 SUPPL-35 Efficacy-New Indication

Label is not available on this site.

03/21/1979 SUPPL-34 Labeling

Label is not available on this site.

02/06/1979 SUPPL-33 Labeling

Label is not available on this site.

01/15/1979 SUPPL-32 Labeling

Label is not available on this site.

11/21/1978 SUPPL-31 Labeling

Label is not available on this site.

11/15/1978 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1992 SUPPL-29 Labeling

Label is not available on this site.

06/18/1993 SUPPL-28 Labeling

Label is not available on this site.

06/13/1991 SUPPL-27 Labeling

Label is not available on this site.

09/03/1982 SUPPL-26 Labeling

Label is not available on this site.

05/10/1995 SUPPL-25 Labeling

Label is not available on this site.

07/29/1982 SUPPL-23 Labeling

Label is not available on this site.

03/12/1986 SUPPL-22 Labeling

Label is not available on this site.

03/12/1986 SUPPL-21 Labeling

Label is not available on this site.

07/15/1982 SUPPL-19 Labeling

Label is not available on this site.

09/07/1984 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/1984 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1983 SUPPL-14 Labeling

Label is not available on this site.

08/24/1983 SUPPL-13 Labeling

Label is not available on this site.

08/05/1983 SUPPL-12 Labeling

Label is not available on this site.

06/21/1983 SUPPL-10 Labeling

Label is not available on this site.

06/20/1983 SUPPL-9 Labeling

Label is not available on this site.

11/19/1981 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1983 SUPPL-7 Labeling

Label is not available on this site.

03/18/1983 SUPPL-6 Labeling

Label is not available on this site.

02/17/1983 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1983 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/14/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/17/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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