Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065007
Company: SUN PHARM INDS LTD

Products on ANDA 065007

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065007

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.