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
ADRENALIN از شرکت PAR STERILE PRODUCTS
New Drug Application (NDA): 204640
Company: PAR STERILE PRODUCTS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADRENALIN | EPINEPHRINE | EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 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 |
|---|---|---|---|---|---|---|---|
| 12/18/2013 | ORIG-1 | Approval |
Type 7 – Drug Already Marketed without Approved NDA |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204640s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/29/2019 | SUPPL-9 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204200Orig1s009,204640Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204200Orig1s009,204640Orig1s009ltr.pdf |
||
| 08/09/2017 | SUPPL-8 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204200Orig1s007,204640Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/204640Orig1s008.pdf |
||
| 05/18/2016 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204200Orig1s005,204640Orig1s003ltr.pdf |
||
| 12/23/2015 | SUPPL-2 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204640s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204640Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/29/2019 | SUPPL-9 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204200Orig1s009,204640Orig1s009lbl.pdf | |
| 08/09/2017 | SUPPL-8 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204200Orig1s007,204640Orig1s008lbl.pdf | |
| 05/18/2016 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204200s005,204640s003lbl.pdf | |
| 12/23/2015 | SUPPL-2 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204640s002lbl.pdf |
| 12/18/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204640s000lbl.pdf |
ADRENALIN
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS; EQ 30MG BASE/30ML (EQ 1MG BASE/ML)
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ADRENALIN | EPINEPHRINE | EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | Yes | AP | 204640 | PAR STERILE PRODUCTS |
| EPINEPHRINE | EPINEPHRINE | EQ 30MG BASE/30ML (EQ 1MG BASE/ML) | SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | Prescription | No | AP | 211880 | INTL MEDICATION SYS |
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