Drugs@FDA: FDA-Approved Drugs
Company: JANSSEN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ERGAMISOL | LEVAMISOLE HYDROCHLORIDE | EQ 50MG BASE | 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 |
---|---|---|---|---|---|---|---|
06/18/1990 | 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 |
---|---|---|---|---|---|
12/20/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
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07/16/1998 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/23/1998 | SUPPL-11 | Labeling |
Label is not available on this site. |
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05/27/1998 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/16/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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11/22/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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10/20/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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04/11/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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12/17/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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12/14/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/26/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/10/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |