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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211813
Company: HETERO LABS

Products on ANDA 211813

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LINEZOLID	LINEZOLID	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211813

LINEZOLID

FOR SUSPENSION;ORAL; 100MG/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LINEZOLID	LINEZOLID	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	211813	HETERO LABS
LINEZOLID	LINEZOLID	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	200068	HIKMA
ZYVOX	LINEZOLID	100MG/5ML	FOR SUSPENSION;ORAL	Prescription	Yes	AB	021132	PFIZER

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