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): 074626
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 | Prescription |
AP |
No | Yes |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 2MG/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 |
|---|---|---|---|---|---|---|---|
| 01/23/1997 | 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 |
|---|---|---|---|---|---|
| 10/11/2019 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2002 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/25/2002 | SUPPL-14 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/08/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/07/2001 | SUPPL-12 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-11 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/22/2001 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/22/1999 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/01/2000 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/01/2000 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 11/23/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BUTORPHANOL TARTRATE PRESERVATIVE FREE
INJECTABLE;INJECTION; 1MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078400 | HIKMA FARMACEUTICA |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074626 | HOSPIRA |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075045 | WEST-WARD PHARMS INT |
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078400 | HIKMA FARMACEUTICA |
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075046 | WEST-WARD PHARMS INT |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074626 | HOSPIRA |
| BUTORPHANOL TARTRATE PRESERVATIVE FREE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075045 | WEST-WARD PHARMS INT |
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