Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074986
Company: MICRO LABS

Products on ANDA 074986

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DICLOFENAC SODIUM	DICLOFENAC SODIUM	50MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DICLOFENAC SODIUM	DICLOFENAC SODIUM	75MG	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074986

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/1999	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74986_Doclofenec%20Sodium_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/74986ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74986_Diclofenac.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2024	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/28/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
05/09/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 074986

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/1999	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/74986_Doclofenec%20Sodium_prntlbl.pdf