Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075983
Company: SPECGX LLC

• REMS

Products on ANDA 075983

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075983

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/25/2002	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75983lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75983ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-12	REMS - PROPOSAL - D-N-A		Label is not available on this site.
11/17/2005	SUPPL-11	Labeling		Label is not available on this site.
08/11/2004	SUPPL-8	Labeling		Label is not available on this site.
11/22/2002	SUPPL-4	Labeling		Label is not available on this site.

Labels for ANDA 075983

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/25/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75983lbl.pdf