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 از شرکت WEST-WARD PHARMS INT
Abbreviated New Drug Application (ANDA): 075046
Company: WEST-WARD PHARMS INT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | Prescription |
AP |
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 |
|---|---|---|---|---|---|---|---|
| 08/12/1998 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75046ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/11/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2001 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/03/2001 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/15/1999 | SUPPL-1 | Labeling |
Label is not available on this site. |
BUTORPHANOL TARTRATE
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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