Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208766
Company: AMNEAL

Products on ANDA 208766

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208766

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208766

ACYCLOVIR

CREAM;TOPICAL; 5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	212361	ALEMBIC
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	208766	AMNEAL
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	208702	PADAGIS ISRAEL
ACYCLOVIR	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	No	AB	206770	ZYDUS LIFESCIENCES
ZOVIRAX	ACYCLOVIR	5%	CREAM;TOPICAL	Prescription	Yes	AB	021478	BAUSCH