Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074556
Company: TEVA

Products on ANDA 074556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR	ACYCLOVIR	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
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 074556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1997	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
02/09/2009	SUPPL-19	Labeling		Label is not available on this site.
04/20/2005	SUPPL-13	Labeling		Label is not available on this site.
01/25/2002	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
08/22/2000	SUPPL-8	Labeling		Label is not available on this site.
03/31/2000	SUPPL-6	Manufacturing (CMC)-Facility		Label is not available on this site.
03/31/2000	SUPPL-5	Manufacturing (CMC)-Facility		Label is not available on this site.
03/31/2000	SUPPL-4	Manufacturing (CMC)-Facility		Label is not available on this site.
09/09/1998	SUPPL-3	Labeling		Label is not available on this site.
12/16/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/16/1997	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 074556

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	074946	STRIDES PHARMA INTL
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	074946	STRIDES PHARMA INTL
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