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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063304
Company: XTTRIUM LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE SOLUTION;TOPICAL 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
07/15/1997 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
05/15/2001 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

05/15/2001 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/03/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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