Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216635
Company: ALKEM LABS LTD

Products on ANDA 216635

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 216635

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2022	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
12/14/2022	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216635

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	ASSERTIO
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	PAR FORM