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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071093
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIOTHIXENE THIOTHIXENE 10MG CAPSULE;ORAL Prescription AB No No
THIOTHIXENE THIOTHIXENE 1MG CAPSULE;ORAL Prescription AB No No
THIOTHIXENE THIOTHIXENE 2MG CAPSULE;ORAL Prescription AB No No
THIOTHIXENE THIOTHIXENE 5MG CAPSULE;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
06/23/1987 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
06/07/2021 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

02/26/2010 SUPPL-24 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

04/30/2009 SUPPL-21 Labeling

Label is not available on this site.

08/19/2008 SUPPL-19 Labeling

Label is not available on this site.

09/05/2002 SUPPL-14 Labeling

Label is not available on this site.

02/05/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/24/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/19/1993 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/31/1990 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/10/1989 SUPPL-7 Labeling

Label is not available on this site.

06/16/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/16/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/04/1988 SUPPL-4 Labeling

Label is not available on this site.

11/09/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/09/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

THIOTHIXENE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOTHIXENE THIOTHIXENE 10MG CAPSULE;ORAL Prescription No AB 215456 AMNEAL
THIOTHIXENE THIOTHIXENE 10MG CAPSULE;ORAL Prescription No AB 071093 MYLAN
THIOTHIXENE THIOTHIXENE 10MG CAPSULE;ORAL Prescription No AB 211642 NOVITIUM PHARMA

CAPSULE;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOTHIXENE THIOTHIXENE 1MG CAPSULE;ORAL Prescription No AB 215456 AMNEAL
THIOTHIXENE THIOTHIXENE 1MG CAPSULE;ORAL Prescription No AB 071093 MYLAN
THIOTHIXENE THIOTHIXENE 1MG CAPSULE;ORAL Prescription No AB 211642 NOVITIUM PHARMA

CAPSULE;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOTHIXENE THIOTHIXENE 2MG CAPSULE;ORAL Prescription No AB 215456 AMNEAL
THIOTHIXENE THIOTHIXENE 2MG CAPSULE;ORAL Prescription No AB 071093 MYLAN
THIOTHIXENE THIOTHIXENE 2MG CAPSULE;ORAL Prescription No AB 211642 NOVITIUM PHARMA

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THIOTHIXENE THIOTHIXENE 5MG CAPSULE;ORAL Prescription No AB 215456 AMNEAL
THIOTHIXENE THIOTHIXENE 5MG CAPSULE;ORAL Prescription No AB 071093 MYLAN
THIOTHIXENE THIOTHIXENE 5MG CAPSULE;ORAL Prescription No AB 211642 NOVITIUM PHARMA
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