Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050653
Company: SCHIFF AND CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACTISITE TETRACYCLINE HYDROCHLORIDE 12.7MG/FIBER FIBER, EXTENDED RELEASE;PERIODONTAL 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
03/25/1994 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/16/1995 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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