Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018655
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORPACE CR DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
NORPACE CR DISOPYRAMIDE PHOSPHATE EQ 150MG BASE CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/20/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
05/17/2000 SUPPL-33 Labeling

Label is not available on this site.

11/10/1998 SUPPL-32 Labeling

Label is not available on this site.

07/17/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1998 SUPPL-30 Labeling

Label is not available on this site.

01/13/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

06/28/1996 SUPPL-28 Labeling

Label is not available on this site.

12/21/1993 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/03/1991 SUPPL-26 Efficacy-New Indication

Label is not available on this site.

01/16/1992 SUPPL-25 Labeling

Label is not available on this site.

11/16/1989 SUPPL-24 Labeling

Label is not available on this site.

10/20/1989 SUPPL-23 Labeling

Label is not available on this site.

02/04/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/28/1987 SUPPL-21 Labeling

Label is not available on this site.

06/30/1987 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/12/1987 SUPPL-19 Labeling

Label is not available on this site.

04/21/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/30/1986 SUPPL-16 Labeling

Label is not available on this site.

05/06/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

11/26/1985 SUPPL-14 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/18/1985 SUPPL-13 Labeling

Label is not available on this site.

01/25/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-11 Labeling

Label is not available on this site.

02/29/1984 SUPPL-10 Labeling

Label is not available on this site.

10/19/1983 SUPPL-9 Labeling

Label is not available on this site.

06/19/1985 SUPPL-8 Efficacy

Label is not available on this site.

09/06/1983 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1983 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-4 Labeling

Label is not available on this site.

09/22/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1982 SUPPL-1 Labeling

Label is not available on this site.

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