Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE;ORAL | Discontinued | None | No | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
MELLARIL | THIORIDAZINE HYDROCHLORIDE | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CONCENTRATE;ORAL | Discontinued | None | No | No |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 |
---|---|---|---|---|---|---|---|
03/15/1962 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/28/2001 | SUPPL-179 | Manufacturing (CMC) |
Label is not available on this site. |
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03/15/2001 | SUPPL-178 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF |
06/15/2001 | SUPPL-177 | Manufacturing (CMC) |
Label is not available on this site. |
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03/01/2000 | SUPPL-176 | Manufacturing (CMC) |
Label is not available on this site. |
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06/19/2000 | SUPPL-175 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-174 | Labeling |
Label is not available on this site. |
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04/15/1999 | SUPPL-173 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/25/1999 | SUPPL-172 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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12/07/2007 | SUPPL-171 | Labeling |
Label is not available on this site. |
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01/15/1997 | SUPPL-170 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/20/1996 | SUPPL-169 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/22/1995 | SUPPL-168 | Manufacturing (CMC) |
Label is not available on this site. |
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12/07/2007 | SUPPL-166 | Labeling |
Label is not available on this site. |
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10/17/1995 | SUPPL-165 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-164 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-160 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-159 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-157 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-154 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-153 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-152 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-150 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-148 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-145 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-139 | Labeling |
Label is not available on this site. |
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12/02/1994 | SUPPL-138 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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12/07/2007 | SUPPL-137 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-136 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-129 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-128 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-126 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-118 | Labeling |
Label is not available on this site. |
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11/28/1994 | SUPPL-117 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-107 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-106 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-105 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-101 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-97 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-96 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-93 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-85 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-77 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-68 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-61 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-59 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-31 | Efficacy |
Label is not available on this site. |
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12/07/2007 | SUPPL-29 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-28 | Labeling |
Label is not available on this site. |