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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062286
Company: TEVA

Products on ANDA 062286

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 062286

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/1982	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
09/29/2015	SUPPL-82	Labeling-Package Insert		Label is not available on this site.
09/29/2015	SUPPL-81	Labeling-Package Insert		Label is not available on this site.
03/17/2009	SUPPL-78	Labeling		Label is not available on this site.
10/21/2004	SUPPL-76	Labeling		Label is not available on this site.
03/14/2002	SUPPL-70	Manufacturing (CMC)-Facility		Label is not available on this site.
02/20/2002	SUPPL-68	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/2001	SUPPL-67	Manufacturing (CMC)-Facility		Label is not available on this site.
07/07/2000	SUPPL-66	Manufacturing (CMC)-Facility		Label is not available on this site.
12/10/1997	SUPPL-65	Manufacturing (CMC)		Label is not available on this site.
08/27/1996	SUPPL-64	Manufacturing (CMC)		Label is not available on this site.
05/15/1996	SUPPL-63	Manufacturing (CMC)		Label is not available on this site.
10/10/1991	SUPPL-62	Labeling		Label is not available on this site.
03/10/1992	SUPPL-61	Labeling		Label is not available on this site.
12/15/1988	SUPPL-60	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 062286

DICLOXACILLIN SODIUM

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	216845	AUROBINDO PHARMA
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 250MG BASE	CAPSULE;ORAL	Prescription	No	AB	062286	TEVA

CAPSULE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	216845	AUROBINDO PHARMA
DICLOXACILLIN SODIUM	DICLOXACILLIN SODIUM	EQ 500MG BASE	CAPSULE;ORAL	Prescription	No	AB	062286	TEVA

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