Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075105
Company: AUROBINDO PHARMA USA

Products on ANDA 075105

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INDAPAMIDE	INDAPAMIDE	1.25MG	TABLET;ORAL	Discontinued	None	No	No
INDAPAMIDE	INDAPAMIDE	2.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075105

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75105ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/22/2001	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 075105

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/23/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-105_Indapamide_prntlbl.pdf