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 APOTEX INC
Abbreviated New Drug Application (ANDA): 075499
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 12/04/2002 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075499_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/05/2021 | SUPPL-28 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-24 | REMS – PROPOSAL – D-N-A |
Label is not available on this site. |
||
| 03/23/2017 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/06/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 03/19/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/28/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |
BUTORPHANOL TARTRATE
SPRAY, METERED;NASAL; 1MG/SPRAY
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 075499 | APOTEX INC |
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 075824 | HIKMA |
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/SPRAY | SPRAY, METERED;NASAL | Prescription | No | AB | 075759 | MYLAN |
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