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
AMICAR از شرکت AKORN
New Drug Application (NDA): 015230
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMICAR | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 06/04/1964 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/03/2009 | SUPPL-37 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/015230s037ltr.pdf |
||
| 08/19/2008 | SUPPL-35 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/015230s035, 015197s043ltr.pdf |
||
| 08/24/2004 | SUPPL-31 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/15197s040,15229s031,15230s031ltr.pdf |
|
| 09/02/2003 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf |
|
| 09/02/2003 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf |
|
| 09/02/2003 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/15230scm028,scf029,scp030ltr.pdf |
|
| 09/14/1999 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/14/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1997 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 11/04/1986 | SUPPL-22 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/10/1982 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 09/22/1982 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/22/1980 | SUPPL-15 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/17/1978 | SUPPL-12 | 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 |
|---|---|---|---|---|---|
| 02/03/2009 | SUPPL-37 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/015230s037lbl.pdf | |
| 08/19/2008 | SUPPL-35 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/015197s043,015230s035lbl.pdf |
AMICAR
SOLUTION;ORAL; 0.25GM/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMICAR | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | Yes | AA | 015230 | AKORN |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 212780 | AMNEAL |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 213825 | BELCHER |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 214140 | LEADING PHARMA LLC |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 212494 | TULEX PHARMS INC |
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | 0.25GM/ML | SOLUTION;ORAL | Prescription | No | AA | 212814 | VISTAPHARM |
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