Drugs@FDA: FDA-Approved Drugs
Company: KING PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TAPAZOLE | METHIMAZOLE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
TAPAZOLE | METHIMAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
06/21/1950 | 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 |
---|---|---|---|---|---|
01/16/2001 | SUPPL-22 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf | |
11/17/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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03/25/1998 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/02/1998 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/20/1995 | SUPPL-18 | Labeling |
Label is not available on this site. |
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08/07/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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06/20/1991 | SUPPL-16 | Labeling |
Label is not available on this site. |
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10/01/1991 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
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02/27/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
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11/13/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-11 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
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09/24/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
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02/25/1983 | SUPPL-8 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/07/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/16/2001 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/007517s022lbl.pdf |