Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070351
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DISOPYRAMIDE PHOSPHATE DISOPYRAMIDE PHOSPHATE EQ 100MG BASE CAPSULE;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
12/17/1985 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
12/01/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/15/1992 SUPPL-21 Labeling

Label is not available on this site.

04/03/1992 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

11/21/1991 SUPPL-17 Labeling

Label is not available on this site.

09/30/1991 SUPPL-16 Labeling

Label is not available on this site.

08/22/1990 SUPPL-15 Labeling

Label is not available on this site.

10/09/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/30/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/22/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/08/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English