Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009008
Company: ORTHO MCNEIL PHARM
Company: ORTHO MCNEIL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SALPIX | ACETRIZOATE SODIUM | 53% | SOLUTION;INTRAUTERINE | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1953 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
|---|---|---|---|---|---|
| 09/24/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/13/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/26/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 01/05/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |