Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018895
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TPN ELECTROLYTES IN PLASTIC CONTAINER | CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE | 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML;16.1MG/ML | INJECTABLE;INJECTION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/20/1984 | 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 |
|---|---|---|---|---|---|
| 06/12/2014 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/14/2003 | SUPPL-13 | Manufacturing (CMC)-Control |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18895scs013ltr.pdf |
| 02/16/2001 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/31/1999 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/09/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/22/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/29/1996 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/17/1997 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1987 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/24/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/31/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/14/1985 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |