Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208702
Company: PADAGIS ISRAEL

Products on ANDA 208702

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208702

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/04/2019	ORIG-1	Approval		STANDARD	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208702Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208702Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/02/2021	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208702

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