An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075211
Company: AUROBINDO PHARMA USA

Products on ANDA 075211

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 075211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/1998	ORIG-1	Approval			Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75211ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/075211_acyclovir_toc.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/07/2009	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
10/21/2004	SUPPL-6	Labeling		Label is not available on this site.
07/31/2002	SUPPL-4	Labeling		Label is not available on this site.
03/13/2002	SUPPL-3	Labeling		Label is not available on this site.
04/18/2001	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/23/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 075211

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

Top