Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019438
Company: ICU MEDICAL INC
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOSYN II 10% | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMINOSYN II 3.5% | AMINO ACIDS | 3.5% (3.5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMINOSYN II 5% | AMINO ACIDS | 5% (5GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMINOSYN II 7% | AMINO ACIDS | 7% (7GM/100ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMINOSYN II 8.5% | AMINO ACIDS | 8.5% (8.5GM/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 |
|---|---|---|---|---|---|---|---|
| 04/03/1986 | 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 |
|---|---|---|---|---|---|
| 10/25/2002 | SUPPL-14 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf |
| 06/06/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/22/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1997 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/11/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1993 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/28/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/30/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/10/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/01/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |