Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019222
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXTROSE 5% IN PLASTIC CONTAINER | DEXTROSE | 50MG/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 |
|---|---|---|---|---|---|---|---|
| 07/13/1984 | 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 |
|---|---|---|---|---|---|
| 01/22/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/17/1998 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/22/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 08/18/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1994 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/11/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |