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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065007
Company: SUN PHARM INDS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
CEPHALEXIN CEPHALEXIN EQ 500MG BASE 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
09/16/1999 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65007ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/02/2004 SUPPL-15 Labeling

Label is not available on this site.

11/03/2003 SUPPL-11 Labeling

Label is not available on this site.

11/03/2003 SUPPL-10 Labeling

Label is not available on this site.

09/05/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

09/05/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

06/29/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/18/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/18/2000 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

03/01/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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