Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008278
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REGITINE | PHENTOLAMINE MESYLATE | 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 01/30/1952 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 04/29/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/05/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/20/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/09/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/14/1986 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/21/1983 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/27/1983 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1985 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/09/1981 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 02/18/1981 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/07/1980 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/11/1977 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/12/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/11/1977 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |