Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205029
Company: BELCHER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPINEPHRINE EPINEPHRINE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION;INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS Prescription None 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
07/29/2014 ORIG-1 Approval Type 7 - Drug Already Marketed without Approved NDA STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205029Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205029Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/23/2021 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205029Orig1s008ltr.pdf
09/10/2021 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205029Orig1s006ltr.pdf
05/18/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s004ltr.pdf
12/03/2015 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/11/2016 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205029Orig1s002ltr.pdf
10/23/2015 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205029Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/10/2021 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029s006lbl.pdf
06/23/2021 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf
06/23/2021 SUPPL-8 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205029Orig1s008lbl.pdf
05/18/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s004lbl.pdf
02/11/2016 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205029s002lbl.pdf
10/23/2015 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205029s001lbl.pdf
07/29/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205029s000lbl.pdf

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