ADRENALIN از شرکت PAR STERILE PRODUCTS

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
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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

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204640s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204640Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204640Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204640Orig1s000SumR.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

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

Review (PDF)

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

Label (PDF)

Letter (PDF)

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)

Label (PDF)

Letter (PDF)

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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