Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017013
Company: ABBOTT
Company: ABBOTT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE | SODIUM CHLORIDE | 20GM/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 10/08/1971 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
|---|---|---|---|---|---|
| 08/27/1996 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/16/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/09/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/21/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 12/11/1980 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/12/1981 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/19/1979 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/08/1979 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/18/1979 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 09/27/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/14/1976 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |