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
ADRENACLICK از شرکت IMPAX
New Drug Application (NDA): 020800
Company: IMPAX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADRENACLICK | EPINEPHRINE | EQ 0.15MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Prescription |
BX |
Yes | Yes |
| ADRENACLICK | EPINEPHRINE | EQ 0.3MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Prescription |
BX |
Yes | Yes |
| TWINJECT 0.15 | EPINEPHRINE | EQ 0.15MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Discontinued |
None |
No | No |
| TWINJECT 0.3 | EPINEPHRINE | EQ 0.3MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 05/30/2003 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20800ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/04/2021 | SUPPL-40 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020800s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020800Orig1s040ltr.pdf |
||
| 08/29/2018 | SUPPL-35 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020800s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020800Orig1s035ltr.pdf |
||
| 05/18/2016 | SUPPL-34 | Labeling-Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020800Orig1s034ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020800Orig1s034pkg.pdf |
||
| 10/17/2014 | SUPPL-30 | Manufacturing (CMC) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s030ltr.pdf |
||
| 10/13/2014 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/23/2014 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/2014 | SUPPL-27 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s027ltr.pdf |
||
| 03/25/2014 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/2014 | SUPPL-24 | Labeling-Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s024ltr.pdf |
||
| 09/06/2013 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020800Orig1s023.pdf |
|
| 01/26/2011 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020800s020ltr.pdf |
||
| 11/25/2009 | SUPPL-18 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf |
||
| 12/28/2006 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020800s011ltr.pdf |
|
| 07/01/2005 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s007ltr.pdf |
|
| 07/07/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s006ltr.pdf |
|
| 02/22/2005 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20800s005ltr.pdf |
|
| 05/28/2004 | SUPPL-1 | Efficacy-New Patient Population |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20800se5-001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/04/2021 | SUPPL-40 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020800s040lbl.pdf | |
| 08/29/2018 | SUPPL-35 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020800s035lbl.pdf | |
| 05/18/2016 | SUPPL-34 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf | |
| 05/18/2016 | SUPPL-34 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf | |
| 10/17/2014 | SUPPL-30 |
Manufacturing (CMC) |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf |
| 07/25/2014 | SUPPL-27 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf | |
| 04/23/2014 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf | |
| 04/23/2014 | SUPPL-24 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf | |
| 01/26/2011 | SUPPL-20 |
Labeling-Patient Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf | |
| 01/26/2011 | SUPPL-20 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf | |
| 01/26/2011 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf | |
| 01/26/2011 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf | |
| 11/25/2009 | SUPPL-18 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf |
ADRENACLICK
There are no Therapeutic Equivalents.
TWINJECT 0.15
There are no Therapeutic Equivalents.
TWINJECT 0.3
There are no Therapeutic Equivalents.
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