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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063024
Company: TEVA

Products on ANDA 063024

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CEPHALEXIN	CEPHALEXIN	EQ 500MG BASE	TABLET;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063024

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/12/1989	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2011	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
11/16/2009	SUPPL-25	Labeling		Label is not available on this site.
04/18/2012	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063024s022lbl.pdf
09/27/2007	SUPPL-21	Labeling		Label is not available on this site.
02/08/2007	SUPPL-20	Labeling		Label is not available on this site.
12/19/2003	SUPPL-17	Labeling		Label is not available on this site.
09/22/2003	SUPPL-16	Labeling		Label is not available on this site.
10/24/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
08/14/2001	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/20/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
07/07/2000	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
01/18/2000	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
07/21/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/28/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
10/04/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/16/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/06/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/13/1993	SUPPL-2	Labeling		Label is not available on this site.
11/12/1992	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 063024

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2012	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063024s022lbl.pdf

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