Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 012402
Company: PROCTER AND GAMBLE
Company: PROCTER AND GAMBLE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IVADANTIN | NITROFURANTOIN SODIUM | EQ 180MG BASE/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 09/15/1960 | ORIG-1 | Approval | Type 2 - New Active Ingredient | 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 |
|---|---|---|---|---|---|
| 04/13/1982 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 07/13/1979 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/06/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 06/06/1979 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |