Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204306
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Over-the-counter None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/06/2019 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
08/06/2020 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

DICLOFENAC SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

GEL;TOPICAL; 1%
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Over-the-counter No 208077 AMNEAL PHARMS
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Over-the-counter No 204306 AUROLIFE PHARMA LLC
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Over-the-counter No 210986 ENCUBE
DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL;TOPICAL Over-the-counter No 211253 PERRIGO PHARMA INTL
VOLTAREN ARTHRITIS PAIN DICLOFENAC SODIUM 1% GEL;TOPICAL Over-the-counter Yes 022122 GLAXOSMITHKLINE CONS

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