Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075677
Company: APOTEX

Products on ANDA 075677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2005	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/06/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075677

ACYCLOVIR

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	075677	APOTEX
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	204313	CADILA
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	201445	CADILA PHARMS LTD
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	206261	CARLSBAD TECHNOLOGY
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	074889	HERITAGE
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	075090	REGCON HOLDINGS
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	074578	TEVA
ACYCLOVIR	ACYCLOVIR	200MG	CAPSULE;ORAL	Prescription	No	AB	212173	YILING