Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088941
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE INTENSOL THIORIDAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE;ORAL 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
12/16/1985 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
11/26/2001 SUPPL-8 Labeling

Label is not available on this site.

08/28/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/28/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/22/1991 SUPPL-5 Labeling

Label is not available on this site.

04/02/1990 SUPPL-4 Labeling

Label is not available on this site.

12/05/1988 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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