Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201107
Company: HETERO LABS LTD III

Products on ANDA 201107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/2016	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201107s000TAltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2019	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/13/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/26/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 201107

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201107Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 201107

ABACAVIR SULFATE

SOLUTION;ORAL; EQ 20MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	077950	AUROBINDO PHARMA LTD
ABACAVIR SULFATE	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	No	AA	201107	HETERO LABS LTD III
ZIAGEN	ABACAVIR SULFATE	EQ 20MG BASE/ML	SOLUTION;ORAL	Prescription	Yes	AA	020978	VIIV HLTHCARE