Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014349
Company: PERSONAL PRODS
Company: PERSONAL PRODS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DELFEN | NONOXYNOL-9 | 12.5% | AEROSOL;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 12/10/1963 | 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 |
|---|---|---|---|---|---|
| 03/27/1989 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/29/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1988 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/18/1986 | SUPPL-30 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 09/18/1984 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/14/1980 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/23/1980 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 10/27/1980 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/06/1980 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 03/24/1980 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1979 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/31/1979 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/31/1979 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/23/1978 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/17/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |