Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012486
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TARACTAN CHLORPROTHIXENE 100MG TABLET;ORAL Discontinued None No No
TARACTAN CHLORPROTHIXENE 50MG TABLET;ORAL Discontinued None No No
TARACTAN CHLORPROTHIXENE 25MG TABLET;ORAL Discontinued None No No
TARACTAN CHLORPROTHIXENE 10MG TABLET;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
05/07/1962 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/1997 SUPPL-49 Labeling

Label is not available on this site.

01/09/1997 SUPPL-48 Labeling

Label is not available on this site.

01/09/1997 SUPPL-47 Labeling

Label is not available on this site.

01/09/1997 SUPPL-46 Labeling

Label is not available on this site.

01/29/1981 SUPPL-45 Labeling

Label is not available on this site.

01/09/1997 SUPPL-44 Labeling

Label is not available on this site.

01/09/1997 SUPPL-40 Labeling

Label is not available on this site.

01/09/1997 SUPPL-36 Labeling

Label is not available on this site.

01/09/1997 SUPPL-31 Labeling

Label is not available on this site.

06/16/1974 SUPPL-26 Labeling

Label is not available on this site.

01/09/1997 SUPPL-12 Labeling

Label is not available on this site.

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