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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216275
Company: INGENUS PHARMS LLC

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

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.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2024 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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 INGENUS PHARMS LLC
DICLOFENAC SODIUM DICLOFENAC SODIUM 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075492 VPNA
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