Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076185
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIMETHYL SULFOXIDE DIMETHYL SULFOXIDE 50% SOLUTION;INTRAVESICAL Prescription AT 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
11/29/2002 ORIG-1 Approval

Label is not available on this site.

DIMETHYL SULFOXIDE

SOLUTION;INTRAVESICAL; 50%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIMETHYL SULFOXIDE DIMETHYL SULFOXIDE 50% SOLUTION;INTRAVESICAL Prescription No AT 076185 MYLAN INSTITUTIONAL
RIMSO-50 DIMETHYL SULFOXIDE 50% SOLUTION;INTRAVESICAL Prescription Yes AT 017788 MYLAN INSTITUTIONAL

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