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
CORPHEDRA از شرکت PAR STERILE PRODUCTS
New Drug Application (NDA): 208943
Company: PAR STERILE PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CORPHEDRA | EPHEDRINE SULFATE | 50MG/ML (50MG/ML) | SOLUTION;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/2017 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208943s000lbl.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/27/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208943s000lbl.pdf |
CORPHEDRA
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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