Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070602
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOTHIXENE THIOTHIXENE 5MG CAPSULE;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
06/05/1987 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
04/25/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/10/2002 SUPPL-17 Labeling

Label is not available on this site.

11/26/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/20/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/28/1994 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/05/1990 SUPPL-12 Labeling

Label is not available on this site.

06/05/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/19/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/19/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/08/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/25/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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