Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091475
Company: HETERO LABS LTD III

Products on ANDA 091475

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LAMIVUDINE	LAMIVUDINE	10MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091475

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2023	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091475s000ltr.pdf

Therapeutic Equivalents for ANDA 091475

LAMIVUDINE

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EPIVIR	LAMIVUDINE	10MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	020596	VIIV HLTHCARE
LAMIVUDINE	LAMIVUDINE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	077695	AUROBINDO PHARMA
LAMIVUDINE	LAMIVUDINE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	203564	CHARTWELL MOLECULAR
LAMIVUDINE	LAMIVUDINE	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	091475	HETERO LABS LTD III