Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074698
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BACLOFEN BACLOFEN 10MG TABLET;ORAL Discontinued None No No
BACLOFEN BACLOFEN 20MG 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
08/20/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/04/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/31/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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