Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216845
Company: AUROBINDO PHARMA

Products on ANDA 216845

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216845

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216845Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 216845

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