Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217010
Company: UMEDICA

Products on ANDA 217010

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217010

DICLOFENAC POTASSIUM

FOR SOLUTION;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CAMBIA	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	Yes	AB	022165	COSETTE
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	216635	ALKEM LABS LTD
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	215375	ANNORA PHARMA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	202964	PH HEALTH
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	218011	TARO
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	215891	TORRENT
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	50MG	FOR SOLUTION;ORAL	Prescription	No	AB	217010	UMEDICA