Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 002282
Company: ISO TEX
Company: ISO TEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INULIN AND SODIUM CHLORIDE | INULIN | 100MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1940 | 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 |
|---|---|---|---|---|---|
| 04/20/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 03/04/1998 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/31/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/1989 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/24/1989 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/05/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/19/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 10/23/1986 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/21/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/14/1976 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/22/1975 | SUPPL-3 | Unspecified |
Label is not available on this site. |