Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087766
Company: ALPHARMA US PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE 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
04/26/1983 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
09/28/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

09/27/1989 SUPPL-8 Labeling

Label is not available on this site.

04/04/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/19/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/25/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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