Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019430
Company: MYLAN SPECIALITY LP
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 | AB | 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 |
|---|---|---|---|---|---|
| 02/10/2023 | SUPPL-106 | Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019430Orig1s106Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019430Orig1s106ltr.pdf | |
| 12/24/2020 | SUPPL-91 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019430Orig1s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019430Orig1s091ltr.pdf | |
| 06/17/2020 | SUPPL-89 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019430s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019430Orig1s089ltr.pdf | |
| 01/31/2020 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019430s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019430Orig1s082ltr.pdf | |
| 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-Patient Package Insert, Labeling-Container/Carton Labels |
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 |
|---|---|---|---|---|---|
| 02/10/2023 | SUPPL-106 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019430Orig1s106Lbl.pdf | |
| 02/10/2023 | SUPPL-106 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019430Orig1s106Lbl.pdf | |
| 02/10/2023 | SUPPL-106 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019430Orig1s106Lbl.pdf | |
| 12/24/2020 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019430Orig1s091lbl.pdf | |
| 12/24/2020 | SUPPL-91 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019430Orig1s091lbl.pdf | |
| 06/17/2020 | SUPPL-89 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019430s089lbl.pdf | |
| 01/31/2020 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019430s082lbl.pdf | |
| 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-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019430s053lbl.pdf | |
| 08/20/2012 | SUPPL-53 | Labeling-Container/Carton Labels | 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.
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS; 0.15MG/DELIVERY
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| EPINEPHRINE (AUTOINJECTOR) | EPINEPHRINE | 0.15MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Prescription | No | AB | 090589 | TEVA PHARMS USA |
| EPIPEN JR. | EPINEPHRINE | 0.15MG/DELIVERY | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Prescription | Yes | AB | 019430 | MYLAN SPECIALITY LP |