Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210078
Company: ONESOURCE SPECIALTY

Products on ANDA 210078

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210078

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/03/2019	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
07/10/2025	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/10/2025	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
07/10/2025	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
07/10/2025	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/10/2025	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 210078

DICLOFENAC POTASSIUM

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	213875	AUROBINDO PHARMA LTD
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	204648	BIONPHARMA
DICLOFENAC POTASSIUM	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	No	AB	210078	ONESOURCE SPECIALTY
ZIPSOR	DICLOFENAC POTASSIUM	25MG	CAPSULE;ORAL	Prescription	Yes	AB	022202	ASSERTIO SPECLTY