AKOVAZ از شرکت EXELA PHARMA

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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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

Label (PDF)

Letter (PDF)

Review

Summary Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208289s000lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208289Orig1s000ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000TOC.cfm
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208289Orig1s000SumR.pdf

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/02/2021 SUPPL-6

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208289s006lbl.pdf

04/08/2020 SUPPL-5 Labeling-Package Insert

Label (PDF)

Letter (PDF)

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

Label (PDF)

Letter (PDF)

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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