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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077309
Company: APOTEX

Products on ANDA 077309

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	AB	No	No
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077309

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2005	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077309ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077309

ACYCLOVIR

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	077309	APOTEX
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	075211	AUROBINDO PHARMA USA
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	202168	CADILA PHARMS LTD
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	075382	CARLSBAD
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	074891	HERITAGE
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	203834	HETERO LABS LTD V
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	209366	SQUARE PHARMS
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	074556	TEVA
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	210401	YILING
ACYCLOVIR	ACYCLOVIR	400MG	TABLET;ORAL	Prescription	No	AB	204314	ZYDUS PHARMS

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	077309	APOTEX
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	075211	AUROBINDO PHARMA USA
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	202168	CADILA PHARMS LTD
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	075382	CARLSBAD
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	074891	HERITAGE
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	203834	HETERO LABS LTD V
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	209366	SQUARE PHARMS
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	074556	TEVA
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	210401	YILING
ACYCLOVIR	ACYCLOVIR	800MG	TABLET;ORAL	Prescription	No	AB	204314	ZYDUS PHARMS

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