Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018947
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SODIUM LACTATE IN PLASTIC CONTAINER | SODIUM LACTATE | 5MEQ/ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/05/1984 | 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 |
|---|---|---|---|---|---|
| 07/15/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/2014 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/2001 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/15/2001 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 03/31/1999 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/31/1999 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/23/2000 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 11/19/1997 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 08/29/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/17/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/21/1988 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/24/1986 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/06/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/28/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/01/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |