Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070101
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE;ORAL Prescription AB 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
02/22/1985 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/29/2015 SUPPL-46 Labeling-Package Insert

Label is not available on this site.

02/08/2001 SUPPL-41 Labeling

Label is not available on this site.

11/01/2000 SUPPL-40 Labeling

Label is not available on this site.

07/07/2000 SUPPL-39 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-38 Manufacturing (CMC)-Facility

Label is not available on this site.

07/14/2000 SUPPL-37 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/14/2000 SUPPL-36 Manufacturing (CMC)-Facility

Label is not available on this site.

07/14/2000 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1999 SUPPL-34 Labeling

Label is not available on this site.

12/10/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/07/1997 SUPPL-32 Labeling

Label is not available on this site.

06/18/1997 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/08/1995 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/23/1995 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/12/1996 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

07/31/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

08/11/1992 SUPPL-25 Labeling

Label is not available on this site.

06/11/1992 SUPPL-24 Labeling

Label is not available on this site.

12/19/1991 SUPPL-23 Labeling

Label is not available on this site.

05/30/1991 SUPPL-22 Labeling

Label is not available on this site.

10/03/1990 SUPPL-21 Labeling

Label is not available on this site.

07/06/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/30/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/10/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/14/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/14/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/10/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/15/1985 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/15/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/15/1985 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/24/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/20/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

DISOPYRAMIDE PHOSPHATE

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

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