Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 006328
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISUPREL | ISOPROTERENOL HYDROCHLORIDE | 10MG | TABLET;RECTAL, SUBLINGUAL | Discontinued | None | No | No |
| ISUPREL | ISOPROTERENOL HYDROCHLORIDE | 15MG | TABLET;RECTAL, SUBLINGUAL | 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 |
|---|---|---|---|---|---|---|---|
| 02/19/1948 | ORIG-1 | Approval | UNKNOWN |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/27/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/13/1985 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 02/04/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 09/12/1980 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 05/12/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/17/1980 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 05/12/1998 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 05/12/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/02/1975 | SUPPL-2 | Labeling |
Label is not available on this site. |