Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014860
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE | CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE | EQ 300MG BASE;EQ 45MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/09/1968 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 05/29/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/03/1987 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 01/26/1984 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 12/04/1986 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 05/15/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/15/1981 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/09/1976 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |