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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074299
Company: ANI PHARMS

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
07/27/1995 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
09/28/2023 SUPPL-30 Labeling-Package Insert

Label is not available on this site.
09/22/2017 SUPPL-27 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
09/12/2001 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.
08/28/2001 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.
08/28/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
06/23/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.
06/23/2000 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.
03/28/2000 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.
08/01/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.
08/01/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.
03/21/2000 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/28/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.
11/23/1999 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.
10/29/1999 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
02/01/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
12/09/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
10/21/1997 SUPPL-6 Labeling

Label is not available on this site.
05/30/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
04/16/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
04/29/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
04/29/1996 SUPPL-2 Labeling

Label is not available on this site.
04/29/1996 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 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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