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
AMINOCAPROIC ACID IN PLASTIC CONTAINER از شرکت HOSPIRA
Abbreviated New Drug Application (ANDA): 070010
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMINOCAPROIC ACID IN PLASTIC CONTAINER | AMINOCAPROIC ACID | 250MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
No | 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 |
|---|---|---|---|---|---|---|---|
| 03/09/1987 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/27/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/15/2002 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/15/2001 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/08/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/20/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/20/1999 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/08/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/03/1996 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/22/1996 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 01/26/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/21/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/03/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
AMINOCAPROIC ACID IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 250MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMINOCAPROIC ACID | AMINOCAPROIC ACID | 250MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071192 | LUITPOLD |
| AMINOCAPROIC ACID IN PLASTIC CONTAINER | AMINOCAPROIC ACID | 250MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070010 | HOSPIRA |
نظرات کاربران