Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203564
Company: CHARTWELL MOLECULAR

Products on ANDA 203564

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 203564

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203564Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2025	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/20/2025	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
08/20/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/20/2025	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
08/20/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203564

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