Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011721
Company: LEDERLE
Company: LEDERLE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEPTAZANE | METHAZOLAMIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
NEPTAZANE | METHAZOLAMIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
01/26/1959 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
01/05/1999 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/12/1992 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/25/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
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03/04/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
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11/25/1991 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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03/13/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
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11/25/1991 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/25/1991 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
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03/13/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |