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
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE
New Drug Application (NDA): 020734
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;10GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;25GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 2.75%;5GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;10GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;20GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;25GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 4.25%;5GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;10GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;15GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;20GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;25GM/100ML | INJECTABLE;INJECTION | Prescription |
None |
No | No |
| CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER | AMINO ACIDS; DEXTROSE | 5%;35GM/100ML | INJECTABLE;INJECTION | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 09/29/1997 | ORIG-1 | Approval |
Type 4 – New Combination |
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 |
|---|---|---|---|---|---|
| 04/13/2021 | SUPPL-37 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020734s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020678Orig1s042, 020734Orig1s037, 204508Orig1s015ltr.pdf |
||
| 10/12/2018 | SUPPL-34 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020734s034lbl.pdf |
|||
| 01/19/2016 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/2016 | SUPPL-25 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020734s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020678Orig1s027,020734Orig1s025ltr.pdf |
||
| 09/15/2014 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020734s019ltr.pdf |
|
| 01/23/2004 | SUPPL-13 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20678slr014,20734slr013ltr.pdf |
|
| 05/21/2003 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20678scs013,20734scs012ltr.pdf |
|
| 07/25/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf |
|
| 07/25/2002 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20678slr010,011and20734slr010,011ltr.pdf |
|
| 02/15/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/04/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/19/2000 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/24/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/25/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-3 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20734S03LTR.PDF |
|
| 05/25/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/13/2021 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020734s037lbl.pdf | |
| 10/12/2018 | SUPPL-34 |
Manufacturing (CMC) |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020734s034lbl.pdf | |
| 09/27/2016 | SUPPL-25 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020734s025lbl.pdf |
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