Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010251
Company: TARGACEPT
Company: TARGACEPT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INVERSINE | MECAMYLAMINE HYDROCHLORIDE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/01/1956 | 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 |
|---|---|---|---|---|---|
| 10/18/2002 | SUPPL-24 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10251scm024ltr.pdf |
| 01/24/2002 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/20/2001 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/31/2000 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/31/1996 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/08/1994 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 09/26/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/06/1988 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/22/1988 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/04/1985 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/06/1985 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 11/14/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 04/30/1980 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/27/1979 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 09/01/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |