Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088004
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription AB No Yes
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription AB No No
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 50MG TABLET;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
11/18/1983 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
02/23/2017 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-35 Labeling

Label is not available on this site.

06/12/2009 SUPPL-34 Labeling

Label is not available on this site.

01/23/2009 SUPPL-33 Labeling

Label is not available on this site.

04/25/2008 SUPPL-31 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/05/2002 SUPPL-27 Labeling

Label is not available on this site.

08/14/2001 SUPPL-26 Labeling

Label is not available on this site.

02/05/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/15/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-20 Labeling

Label is not available on this site.

05/17/1991 SUPPL-19 Labeling

Label is not available on this site.

10/31/1990 SUPPL-18 Labeling

Label is not available on this site.

03/30/1990 SUPPL-17 Labeling

Label is not available on this site.

01/04/1990 SUPPL-16 Labeling

Label is not available on this site.

03/29/1989 SUPPL-15 Bioequivalence

Label is not available on this site.

12/20/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/20/1990 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-12 Labeling

Label is not available on this site.

05/06/1988 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/20/1988 SUPPL-10 Labeling

Label is not available on this site.

04/10/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/03/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/28/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

THIORIDAZINE HYDROCHLORIDE

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 088004 MYLAN
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 089953 SUN PHARM INDUSTRIES

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 088004 MYLAN
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 089953 SUN PHARM INDUSTRIES

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 088004 MYLAN
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 25MG TABLET;ORAL Prescription No AB 089953 SUN PHARM INDUSTRIES

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 088004 MYLAN
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 089953 SUN PHARM INDUSTRIES

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