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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074461
Company: RISING

Products on ANDA 074461

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDAPAMIDE	INDAPAMIDE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
INDAPAMIDE	INDAPAMIDE	1.25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074461

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.

Therapeutic Equivalents for ANDA 074461

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	074299	ANI PHARMS
INDAPAMIDE	INDAPAMIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	074461	RISING

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	074299	ANI PHARMS
INDAPAMIDE	INDAPAMIDE	1.25MG	TABLET;ORAL	Prescription	No	AB	074461	RISING

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