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
BUTORPHANOL TARTRATE PRESERVATIVE FREE از شرکت HOSPIRA
Abbreviated New Drug Application (ANDA): 075170
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 2MG/ML | 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1998 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75170ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/20/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/13/2001 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 12/01/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/18/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 07/22/1999 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
نظرات کاربران