Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065059
Company: SUN PHARM INDS LTD

Products on ANDA 065059

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN	AMOXICILLIN	500MG	TABLET;ORAL	Discontinued	None	No	No
AMOXICILLIN	AMOXICILLIN	875MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065059

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/24/2000	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/65-059_Amoxicillin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65059ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/65-059_Amoxicillin.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/30/2008	SUPPL-10	Labeling		Label is not available on this site.
07/31/2006	SUPPL-7	Labeling		Label is not available on this site.
05/04/2006	SUPPL-6	Labeling		Label is not available on this site.
11/29/2005	SUPPL-4	Labeling		Label is not available on this site.
04/23/2004	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 065059

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/65-059_Amoxicillin_prntlbl.pdf