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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216275
Company: RICONPHARMA LLC

Products on ANDA 216275

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216275

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216275

DICLOFENAC SODIUM

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076201	DEXCEL LTD
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	216275	RICONPHARMA LLC
DICLOFENAC SODIUM	DICLOFENAC SODIUM	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	075492	VPNA

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