Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007936
Company: CHATTEM
Company: CHATTEM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SELSUN | SELENIUM SULFIDE | 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | LOTION/SHAMPOO;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 05/17/1951 | 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 |
|---|---|---|---|---|---|
| 06/24/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/19/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/17/1988 | SUPPL-17 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/23/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 09/15/1982 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/26/1983 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 01/09/1981 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/16/1979 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1979 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/19/1977 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/07/1977 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/07/1977 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/29/1976 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/01/1976 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |