Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074498
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDAPAMIDE INDAPAMIDE 2.5MG TABLET;ORAL Discontinued None No No
INDAPAMIDE INDAPAMIDE 1.25MG TABLET;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
10/31/1996 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
08/30/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

06/18/2001 SUPPL-7 Labeling

Label is not available on this site.

07/07/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

03/09/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/04/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/12/1998 SUPPL-3 Labeling

Label is not available on this site.

02/12/1998 SUPPL-2 Manufacturing (CMC)-New Strength

Label is not available on this site.

06/11/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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