Drugs@FDA: FDA Approved Drug Products

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

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

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