Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050497
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TICAR TICARCILLIN DISODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
TICAR TICARCILLIN DISODIUM EQ 3GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
TICAR TICARCILLIN DISODIUM EQ 6GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
TICAR TICARCILLIN DISODIUM EQ 20GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
TICAR TICARCILLIN DISODIUM EQ 30GM 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
11/09/1976 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/03/2003 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

08/02/2001 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/2001 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1998 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

08/29/1997 SUPPL-54 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/23/1997 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1996 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

02/06/1996 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/1994 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

11/09/1995 SUPPL-49 Labeling

Label is not available on this site.

04/07/1993 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

12/22/1992 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

12/30/1992 SUPPL-45 Labeling

Label is not available on this site.

12/30/1992 SUPPL-44 Labeling

Label is not available on this site.

04/13/1993 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

12/30/1992 SUPPL-42 Labeling

Label is not available on this site.

05/28/1992 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

01/02/1992 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

02/26/1990 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/02/1992 SUPPL-38 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/14/1992 SUPPL-37 Labeling

Label is not available on this site.

08/30/1989 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

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