Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017447
Company: GD SEARLE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORPACE DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE;ORAL Prescription AB Yes No
NORPACE DISOPYRAMIDE PHOSPHATE EQ 150MG BASE CAPSULE;ORAL Prescription AB 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
09/01/1977 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
05/17/2000 SUPPL-55 Labeling

Label is not available on this site.

11/10/1998 SUPPL-54 Labeling

Label is not available on this site.

07/17/1998 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1998 SUPPL-52 Labeling

Label is not available on this site.

01/13/1997 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/28/1996 SUPPL-50 Labeling

Label is not available on this site.

02/09/1996 SUPPL-49 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/03/1991 SUPPL-48 Efficacy-New Indication

Label is not available on this site.

01/16/1992 SUPPL-47 Labeling

Label is not available on this site.

11/16/1989 SUPPL-46 Labeling

Label is not available on this site.

10/20/1989 SUPPL-45 Labeling

Label is not available on this site.

02/04/1988 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

08/28/1987 SUPPL-43 Labeling

Label is not available on this site.

08/28/1987 SUPPL-42 Labeling

Label is not available on this site.

02/12/1987 SUPPL-41 Labeling

Label is not available on this site.

05/30/1986 SUPPL-39 Labeling

Label is not available on this site.

06/04/1986 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

06/18/1985 SUPPL-37 Labeling

Label is not available on this site.

01/25/1985 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/19/1985 SUPPL-34 Labeling

Label is not available on this site.

02/29/1984 SUPPL-33 Labeling

Label is not available on this site.

09/14/1983 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/03/1983 SUPPL-31 Labeling

Label is not available on this site.

09/06/1983 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1983 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/21/1982 SUPPL-26 Labeling

Label is not available on this site.

06/19/1985 SUPPL-25 Labeling

Label is not available on this site.

06/17/1982 SUPPL-24 Labeling

Label is not available on this site.

11/30/1981 SUPPL-23 Labeling

Label is not available on this site.

02/20/1981 SUPPL-22 Labeling

Label is not available on this site.

06/19/1985 SUPPL-21 Labeling

Label is not available on this site.

11/30/1981 SUPPL-20 Labeling

Label is not available on this site.

01/30/1981 SUPPL-19 Labeling

Label is not available on this site.

10/17/1980 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/15/1980 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1980 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/23/1979 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/30/1980 SUPPL-13 Labeling

Label is not available on this site.

01/30/1980 SUPPL-12 Labeling

Label is not available on this site.

01/30/1980 SUPPL-11 Labeling

Label is not available on this site.

01/30/1980 SUPPL-10 Labeling

Label is not available on this site.

01/30/1980 SUPPL-9 Labeling

Label is not available on this site.

04/26/1979 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

09/20/1978 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/19/1979 SUPPL-3 Efficacy

Label is not available on this site.

03/02/1978 SUPPL-2 Labeling

Label is not available on this site.

03/02/1978 SUPPL-1 Labeling

Label is not available on this site.

NORPACE

CAPSULE;ORAL; EQ 100MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 070173 MAYNE PHARMA
DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE;ORAL Prescription No AB 070101 TEVA
NORPACE DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE;ORAL Prescription Yes AB 017447 GD SEARLE LLC

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 070173 MAYNE PHARMA
DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 150MG BASE CAPSULE;ORAL Prescription No AB 070102 TEVA
NORPACE DISOPYRAMIDE PHOSPHATE EQ 150MG BASE CAPSULE;ORAL Prescription Yes AB 017447 GD SEARLE LLC

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