Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206298
Company: TARO

Products on ANDA 206298

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL;TOPICAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206298

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206298Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2023	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/28/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/28/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206298

DICLOFENAC SODIUM

GEL;TOPICAL; 3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL;TOPICAL	Prescription	No	AB	206493	ACTAVIS MID ATLANTIC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL;TOPICAL	Prescription	No	AB	212351	ALEMBIC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL;TOPICAL	Prescription	No	AB	200936	AMNEAL
DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL;TOPICAL	Prescription	No	AB	208301	GLENMARK PHARMS LTD
DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL;TOPICAL	Prescription	No	AB	210893	PADAGIS ISRAEL
DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL;TOPICAL	Prescription	No	AB	206298	TARO