Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200068
Company: HIKMA

Products on ANDA 200068

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 200068

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2015	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200068Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200068Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/08/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/08/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200068

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