Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065016
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMOXICILLIN AMOXICILLIN 250MG CAPSULE;ORAL Discontinued None No No
AMOXICILLIN AMOXICILLIN 500MG CAPSULE;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
04/08/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65016ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/30/2008 SUPPL-22 Labeling

Label is not available on this site.

07/31/2006 SUPPL-19 Labeling

Label is not available on this site.

05/04/2006 SUPPL-18 Labeling

Label is not available on this site.

11/29/2005 SUPPL-14 Labeling

Label is not available on this site.

04/23/2004 SUPPL-12 Labeling

Label is not available on this site.

11/10/2003 SUPPL-6 Labeling

Label is not available on this site.

12/22/2000 SUPPL-2 Labeling

Label is not available on this site.

06/29/2000 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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