اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
AMINOSYN 10% از شرکت ICU MEDICAL INC
New Drug Application (NDA): 017673
Company: ICU MEDICAL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOSYN 10% | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 10% (PH6) | AMINO ACIDS | 10% (10GM/100ML) | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 5% | AMINO ACIDS | 5% (5GM/100ML) | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 7% | AMINO ACIDS | 7% (7GM/100ML) | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 7% (PH6) | AMINO ACIDS | 7% (7GM/100ML) | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 8.5% | AMINO ACIDS | 8.5% (8.5GM/100ML) | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 8.5% (PH6) | AMINO ACIDS | 8.5% (8.5GM/100ML) | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 8.5% W/ ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE | 8.5%;102MG/100ML;522MG/100ML;410MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| AMINOSYN 8.5% W/ELECTROLYTES | AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC | 8.5%;102MG/100ML;487MG/100ML;28MG/100ML;425MG/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 |
|---|---|---|---|---|---|---|---|
| 12/03/1975 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 07/28/2016 | SUPPL-91 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/2016 | SUPPL-90 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2013 | SUPPL-89 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2004 | SUPPL-69 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17673scp069ltr.pdf |
|
| 03/28/2003 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673scs067ltr.pdf |
|
| 10/25/2002 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17673scm066,17789scm052,etc,ltr.pdf |
|
| 06/12/2003 | SUPPL-65 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17673slr065,17789slr051ltr.pdf |
|
| 05/05/1997 | SUPPL-64 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1996 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1994 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1993 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/18/1992 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1992 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/13/1987 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 07/13/1987 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/18/1985 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/1985 | SUPPL-50 | Labeling |
Label is not available on this site. |
||
| 03/11/1985 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 03/11/1985 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/1984 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 10/13/1983 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1983 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/05/1983 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1983 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1983 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1982 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 06/29/1982 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1982 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 01/20/1982 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 04/10/1985 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 05/16/1981 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/02/1981 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1980 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/29/1981 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 05/29/1981 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1980 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1979 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1979 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 09/04/1979 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/02/1979 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/1979 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/16/1979 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/19/1978 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1979 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 03/22/1978 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/17/1978 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/09/1979 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/04/1977 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1977 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/13/1977 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1977 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/08/1977 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/26/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/09/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1978 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1978 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/27/1976 | SUPPL-5 | Efficacy |
Label is not available on this site. |
||
| 08/27/1976 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/05/1976 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/1978 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/1978 | SUPPL-1 | Labeling |
Label is not available on this site. |
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