Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070173
Company: MAYNE PHARMA
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
DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 150MG 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
05/31/1985 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
04/25/2001 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/07/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/2001 SUPPL-25 Labeling

Label is not available on this site.

09/12/2000 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/2000 SUPPL-23 Labeling

Label is not available on this site.

07/26/1999 SUPPL-22 Labeling

Label is not available on this site.

03/03/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/14/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/17/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/23/1996 SUPPL-17 Labeling

Label is not available on this site.

11/24/1992 SUPPL-16 Labeling

Label is not available on this site.

10/02/1991 SUPPL-15 Labeling

Label is not available on this site.

01/28/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/16/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/25/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/24/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/24/1985 SUPPL-1 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

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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