Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074722
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDAPAMIDE INDAPAMIDE 1.25MG TABLET;ORAL Prescription AB No No
INDAPAMIDE INDAPAMIDE 2.5MG 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
06/17/1996 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
02/05/2013 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

01/22/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/2001 SUPPL-5 Labeling

Label is not available on this site.

08/03/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/12/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/23/1997 SUPPL-2 Labeling

Label is not available on this site.

07/16/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

INDAPAMIDE

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

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

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