Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NOVAFED | PSEUDOEPHEDRINE HYDROCHLORIDE | 120MG | CAPSULE, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 08/29/1975 | 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 |
|---|---|---|---|---|---|
| 06/21/1996 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 06/24/1992 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/06/1992 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/06/1984 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/09/1983 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 02/02/1982 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 10/23/1981 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 10/09/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1981 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/09/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 09/15/1980 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 11/09/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 07/03/1980 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 07/03/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/06/1978 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/02/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 08/11/1978 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/11/1977 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/18/1977 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/17/1976 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/07/1976 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/18/1977 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/17/1976 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/27/1976 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 02/27/1976 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 01/27/1976 | SUPPL-2 | Labeling |
Label is not available on this site. |