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
AKOVAZ از شرکت EXELA PHARMA
New Drug Application (NDA): 208289
Company: EXELA PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AKOVAZ | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription |
AP |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/2016 | ORIG-1 | Approval |
Type 7 – Drug Already Marketed without Approved NDA |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/02/2021 | SUPPL-6 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208289s006lbl.pdf |
|||
| 04/08/2020 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208289s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208289Orig1s005ltr.pdf |
||
| 08/10/2018 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208289s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208289Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/02/2021 | SUPPL-6 |
Manufacturing (CMC) |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208289s006lbl.pdf | |
| 04/08/2020 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208289s005lbl.pdf | |
| 08/10/2018 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208289s002lbl.pdf | |
| 04/29/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf |
AKOVAZ
SOLUTION;INTRAVENOUS; 50MG/ML (50MG/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AKOVAZ | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | Yes | AP | 208289 | EXELA PHARMA |
| CORPHEDRA | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208943 | PAR STERILE PRODUCTS |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 208609 | AKORN |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212932 | AMNEAL |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214579 | AUROBINDO PHARMA LTD |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 212649 | DR REDDYS LABS LTD |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209646 | FRESENIUS KABI USA |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 214334 | HIKMA |
| EPHEDRINE SULFATE | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | No | AP | 209784 | SANDOZ INC |
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