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
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER از شرکت BAXTER HLTHCARE
New Drug Application (NDA): 017865
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER | GLYCINE | 1.5GM/100ML | SOLUTION;IRRIGATION | Prescription |
AT |
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 |
|---|---|---|---|---|---|---|---|
| 05/30/1980 | 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 |
|---|---|---|---|---|---|
| 09/26/2014 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/2006 | SUPPL-45 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017865s045ltr.pdf |
|
| 08/14/2001 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-41 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr041ltr.pdf |
|
| 09/03/2002 | SUPPL-40 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr040ltr.pdf |
|
| 11/24/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-38 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17865slr038ltr.pdf |
|
| 04/29/1997 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1994 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1994 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1993 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1991 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/08/1991 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/17/1982 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/22/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/13/1981 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/29/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/29/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/06/1980 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/31/1980 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
SOLUTION;IRRIGATION; 1.5GM/100ML
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER | GLYCINE | 1.5GM/100ML | SOLUTION;IRRIGATION | Prescription | Yes | AT | 017865 | BAXTER HLTHCARE |
| GLYCINE 1.5% IN PLASTIC CONTAINER | GLYCINE | 1.5GM/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 016784 | B BRAUN |
| GLYCINE 1.5% IN PLASTIC CONTAINER | GLYCINE | 1.5GM/100ML | SOLUTION;IRRIGATION | Prescription | No | AT | 018315 | ICU MEDICAL INC |
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