Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211871
Company: PADAGIS US

Products on ANDA 211871

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PODOFILOX	PODOFILOX	0.5%	GEL;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211871

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/22/2023	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
11/22/2023	SUPPL-1			Label is not available on this site.

Therapeutic Equivalents for ANDA 211871

PODOFILOX

GEL;TOPICAL; 0.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CONDYLOX	PODOFILOX	0.5%	GEL;TOPICAL	Prescription	Yes	AB	020529	ALLERGAN
PODOFILOX	PODOFILOX	0.5%	GEL;TOPICAL	Prescription	No	AB	211871	PADAGIS US