Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064013
Company: TEVA

Products on ANDA 064013

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN	AMOXICILLIN	250MG	TABLET, CHEWABLE;ORAL	Prescription	None	No	Yes
AMOXICILLIN	AMOXICILLIN	125MG	TABLET, CHEWABLE;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064013

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1992	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
05/01/2024	SUPPL-64	Labeling-Package Insert		Label is not available on this site.
01/03/2024	SUPPL-61	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
12/04/2019	SUPPL-57	Labeling-Package Insert		Label is not available on this site.
05/18/2017	SUPPL-56	Labeling-Package Insert		Label is not available on this site.
05/18/2017	SUPPL-55	Labeling-Package Insert		Label is not available on this site.
09/10/2015	SUPPL-49	Labeling-Package Insert		Label is not available on this site.
02/02/2009	SUPPL-45	Labeling		Label is not available on this site.
07/17/2008	SUPPL-44	Labeling		Label is not available on this site.
05/31/2007	SUPPL-41	Labeling		Label is not available on this site.
08/29/2003	SUPPL-36	Labeling		Label is not available on this site.
12/09/2002	SUPPL-32	Manufacturing (CMC)-Facility		Label is not available on this site.
09/10/2002	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
03/14/2002	SUPPL-29	Manufacturing (CMC)-Facility		Label is not available on this site.
03/20/2002	SUPPL-28	Manufacturing (CMC)-Facility		Label is not available on this site.
03/20/2002	SUPPL-27	Manufacturing (CMC)-Facility		Label is not available on this site.
07/13/2001	SUPPL-26	Labeling		Label is not available on this site.
09/10/2001	SUPPL-25	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/10/2001	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
09/10/2001	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
07/27/2001	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
03/23/2001	SUPPL-21	Labeling		Label is not available on this site.
05/15/2001	SUPPL-20	Manufacturing (CMC)-Facility		Label is not available on this site.
01/04/2001	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/07/2000	SUPPL-18	Manufacturing (CMC)-Facility		Label is not available on this site.
06/12/2000	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
04/06/1999	SUPPL-16	Labeling		Label is not available on this site.
08/28/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/05/1996	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/05/1996	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/03/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/05/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
04/01/1996	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/28/1996	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/12/1993	SUPPL-7	Labeling		Label is not available on this site.
08/26/1993	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/12/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
05/13/1993	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/11/1995	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/11/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/11/1995	SUPPL-1	Labeling		Label is not available on this site.