Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018257
Company: ASTRAZENECA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TONOCARD TOCAINIDE HYDROCHLORIDE 400MG TABLET;ORAL Discontinued None No No
TONOCARD TOCAINIDE HYDROCHLORIDE 600MG TABLET;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
11/09/1984 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
10/24/2001 SUPPL-29 Labeling

Label is not available on this site.

01/18/2001 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/02/2000 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

07/07/1999 SUPPL-26 Labeling

Label is not available on this site.

10/27/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/10/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

11/28/1995 SUPPL-23 Labeling

Label is not available on this site.

10/08/1992 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1992 SUPPL-20 Labeling

Label is not available on this site.

07/10/1989 SUPPL-19 Labeling

Label is not available on this site.

12/07/1989 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/07/1987 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/01/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/28/1987 SUPPL-14 Labeling

Label is not available on this site.

01/21/1987 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1988 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1986 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1985 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/1986 SUPPL-8 Labeling

Label is not available on this site.

05/13/1985 SUPPL-7 Labeling

Label is not available on this site.

05/13/1985 SUPPL-6 Labeling

Label is not available on this site.

01/30/1985 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/26/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/25/1985 SUPPL-2 Labeling

Label is not available on this site.

02/25/1985 SUPPL-1 Labeling

Label is not available on this site.

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