Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206411
Company: ZYDUS LIFESCIENCES

Products on ANDA 206411

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206411

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2018	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
04/28/2021	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206411

DICLOFENAC SODIUM

SOLUTION;TOPICAL; 1.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	206116	AMNEAL PHARMS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	206655	EPIC PHARMA LLC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	204132	LUPIN LTD
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	205878	NOVEL LABS INC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	203818	TARO
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	202852	WATSON LABS INC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	1.5%	SOLUTION;TOPICAL	Prescription	No	AT	206411	ZYDUS LIFESCIENCES