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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204990
Company: CHARTWELL RX

Products on ANDA 204990

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204990

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/28/2017	ORIG-1	Approval		STANDARD	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204990Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204990Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/24/2020	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
02/24/2020	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/24/2020	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204990

ABACAVIR SULFATE AND LAMIVUDINE

TABLET;ORAL; EQ 600MG BASE;300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	090159	AUROBINDO PHARMA LTD
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	204990	CHARTWELL RX
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	091144	CIPLA
ABACAVIR SULFATE AND LAMIVUDINE	ABACAVIR SULFATE; LAMIVUDINE	EQ 600MG BASE;300MG	TABLET;ORAL	Prescription	No	AB	216332	LAURUS

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