Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076763
Company: PADAGIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE;ORAL Prescription AB 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
10/28/2005 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
09/10/2007 SUPPL-6 Labeling

Label is not available on this site.

CLOTRIMAZOLE

TROCHE/LOZENGE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE;ORAL Prescription No AB 076387 HIKMA
CLOTRIMAZOLE CLOTRIMAZOLE 10MG TROCHE/LOZENGE;ORAL Prescription No AB 076763 PADAGIS US

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