Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017788
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIMSO-50 DIMETHYL SULFOXIDE 50% SOLUTION;INTRAVESICAL Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/04/1978 ORIG-1 Approval Type 1 - New Molecular Entity 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
08/27/2015 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

08/28/2014 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

06/26/2013 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/28/2008 SUPPL-19 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/04/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/23/1989 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/12/1988 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1980 SUPPL-2 Labeling

Label is not available on this site.

09/29/1980 SUPPL-1 Labeling

Label is not available on this site.

RIMSO-50

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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