Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208198
Company: AMNEAL

Products on ANDA 208198

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208198

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/18/2022	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
11/21/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208198

DICLOFENAC SODIUM

SOLUTION;TOPICAL; 2%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	212506	ALEMBIC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	208198	AMNEAL
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	207714	APOTEX
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	213040	AUROLIFE PHARMA LLC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	217646	ENCUBE
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	208021	LUPIN PHARMS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	208098	SUN PHARMA CANADA