Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200936
Company: AMNEAL

Products on ANDA 200936

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200936

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/28/2013	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200936Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200936Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/200936Orig1s001.pdf

Labels for ANDA 200936

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200936Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 200936

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