Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207714
Company: APOTEX

Products on ANDA 207714

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 207714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2022	ORIG-1	Approval		STANDARD	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207714Orig1s000TA_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207714Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 207714

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	208021	LUPIN PHARMS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	2%	SOLUTION;TOPICAL	Prescription	No	AB	208098	TARO