Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071554
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOTHIXENE HYDROCHLORIDE THIOTHIXENE HYDROCHLORIDE EQ 5MG BASE/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
10/16/1987 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
09/11/2002 SUPPL-16 Labeling

Label is not available on this site.

10/31/2001 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

06/17/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/11/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/17/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/17/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/07/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/14/1990 SUPPL-1 Labeling

Label is not available on this site.

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