Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019430
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPI E Z PEN JR EPINEPHRINE 0.15MG/DELIVERY INJECTABLE;INTRAMUSCULAR Discontinued None No No
EPIPEN EPINEPHRINE 0.3MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Prescription AB Yes Yes
EPIPEN E Z PEN EPINEPHRINE 0.3MG/DELIVERY INJECTABLE;INTRAMUSCULAR Discontinued None No No
EPIPEN JR. EPINEPHRINE 0.15MG/DELIVERY INJECTABLE;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
12/22/1987 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/23/2018 SUPPL-74 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019430s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019430Orig1s074Ltr.pdf
04/28/2017 SUPPL-67 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019430s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019430Orig1s067ltr.pdf
05/18/2016 SUPPL-61 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019430Orig1s061ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/019430Orig1s061pkg.pdf
03/03/2016 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

04/30/2014 SUPPL-59 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019430s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430Orig1s059ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/019430Orig1s059.pdf
07/17/2014 SUPPL-58 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/19430Orig1s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019430orig1s058ltr.pdf
12/13/2013 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

11/08/2013 SUPPL-56 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s056.pdf
09/16/2013 SUPPL-55 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s055.pdf
07/23/2013 SUPPL-54 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/019430Orig1s054.pdf
08/20/2012 SUPPL-53 Labeling-Container/Carton Labels, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019430Orig1s053ltr.pdf
05/19/2009 SUPPL-47 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019430s047ltr.pdf
09/26/2008 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019430s044ltr.pdf
12/17/2003 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19430slr025ltr.pdf
12/19/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/21/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/28/2002 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/16/2002 SUPPL-15 Manufacturing (CMC)-Expiration Date Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/019430Orig1s015.pdf
02/20/2002 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/2001 SUPPL-12 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19430s12lbl.pdf
01/11/2001 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2000 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/05/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/15/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/25/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/24/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/25/1996 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/02/1989 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019430Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/23/2018 SUPPL-74 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019430s074lbl.pdf
04/28/2017 SUPPL-67 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019430s067lbl.pdf
05/18/2016 SUPPL-61 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf
05/18/2016 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019430s061lbl.pdf
07/17/2014 SUPPL-58 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/19430Orig1s058lbl.pdf
04/30/2014 SUPPL-59 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019430s059lbl.pdf
08/20/2012 SUPPL-53 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf
08/20/2012 SUPPL-53 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf
09/26/2008 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019430s044lbl.pdf
08/27/2001 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19430s12lbl.pdf

EPI E Z PEN JR

There are no Therapeutic Equivalents.

EPIPEN

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS; 0.3MG/DELIVERY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EPINEPHRINE (AUTOINJECTOR) EPINEPHRINE 0.3MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Prescription No AB 090589 TEVA PHARMS USA
EPIPEN EPINEPHRINE 0.3MG/DELIVERY INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS Prescription Yes AB 019430 MYLAN SPECIALITY LP

EPIPEN E Z PEN

There are no Therapeutic Equivalents.

EPIPEN JR.

There are no Therapeutic Equivalents.

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