Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074461
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDAPAMIDE INDAPAMIDE 2.5MG TABLET;ORAL Prescription AB No Yes
INDAPAMIDE INDAPAMIDE 1.25MG TABLET;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
03/27/1996 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
01/25/2010 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/08/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/2002 SUPPL-7 Labeling

Label is not available on this site.

06/14/2001 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/20/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/15/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-2 Labeling

Label is not available on this site.

03/26/1997 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

INDAPAMIDE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDAPAMIDE INDAPAMIDE 2.5MG TABLET;ORAL Prescription No AB 074722 ACTAVIS ELIZABETH
INDAPAMIDE INDAPAMIDE 2.5MG TABLET;ORAL Prescription No AB 075201 AMERIGEN PHARMS LTD
INDAPAMIDE INDAPAMIDE 2.5MG TABLET;ORAL Prescription No AB 074299 ANI PHARMS INC
INDAPAMIDE INDAPAMIDE 2.5MG TABLET;ORAL Prescription No AB 074461 MYLAN

TABLET;ORAL; 1.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDAPAMIDE INDAPAMIDE 1.25MG TABLET;ORAL Prescription No AB 074722 ACTAVIS ELIZABETH
INDAPAMIDE INDAPAMIDE 1.25MG TABLET;ORAL Prescription No AB 075201 AMERIGEN PHARMS LTD
INDAPAMIDE INDAPAMIDE 1.25MG TABLET;ORAL Prescription No AB 074299 ANI PHARMS INC
INDAPAMIDE INDAPAMIDE 1.25MG TABLET;ORAL Prescription No AB 074461 MYLAN

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