Drugs@FDA: FDA-Approved Drugs

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

• REMS

Products on ANDA 75983

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

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