Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075962
Company: WATSON LABS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/24/2002 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75962lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75962ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075962_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-9 REMS - PROPOSAL - D-N-A

Label is not available on this site.

11/18/2004 SUPPL-6 Labeling

Label is not available on this site.

01/03/2005 SUPPL-5 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/24/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/N75962lbl.pdf

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