Application 019430
- Type
- NDA
- Sponsor
- MYLAN SPECIALITY LP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | EPIPEN | EPINEPHRINE | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 0.3MG/DELIVERY | Yes | Yes |
| 002 | EPIPEN JR. | EPINEPHRINE | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 0.15MG/DELIVERY | Yes | Yes |
| 003 | EPIPEN E Z PEN | EPINEPHRINE | INJECTABLE;INTRAMUSCULAR | 0.3MG/DELIVERY | No | No |
| 004 | EPI E Z PEN JR | EPINEPHRINE | INJECTABLE;INTRAMUSCULAR | 0.15MG/DELIVERY | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 49502-101 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-101 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-101 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-101 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-101 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-101 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-102 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-102 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-102 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-102 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-102 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-102 | Epinephrine | Epinephrine | Mylan Specialty L.P. | NDA AUTHORIZED GENERIC | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-500 | EPIPEN | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 49502-501 | EPIPEN JR | epinephrine | Mylan Specialty L.P. | NDA | Current |
| 50090-1243 | EPIPEN JR | epinephrine | A-S Medication Solutions | NDA | Current |
| 50090-2733 | Epinephrine | Epinephrine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-2734 | Epinephrine | Epinephrine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-4543 | Epinephrine | Epinephrine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-4543 | Epinephrine | Epinephrine | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 51662-1224 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1224 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1224 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1224 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1225 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1225 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1225 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 51662-1225 | EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | NDA | Current |
| 55045-3207 | EpiPen | Epinephrine | Dispensing Solutions, Inc. | NDA | Current |
| 55045-3598 | EpiPen Jr | Epinephrine | Dispensing Solutions, Inc. | NDA | Current |
| 64725-0500 | EPIPEN | epinephrine | TYA Pharmaceuticals | NDA | Current |
| 64725-0501 | EPIPEN JR | epinephrine | TYA Pharmaceuticals | NDA | Current |
| 70518-1224 | EPIPEN | epinephrine | REMEDYREPACK INC. | NDA | Current |
| 70518-1224 | EPIPEN | epinephrine | REMEDYREPACK INC. | NDA | Current |
| 70518-1224 | EPIPEN | epinephrine | REMEDYREPACK INC. | NDA | Current |
| 70518-1224 | EPIPEN | epinephrine | REMEDYREPACK INC. | NDA | Current |
| 71872-7134 | Epinephrine | Epinephrine | Medical Purchasing Solutions, LLC | NDA AUTHORIZED GENERIC | Current |
| 71872-7134 | Epinephrine | Epinephrine | Medical Purchasing Solutions, LLC | NDA AUTHORIZED GENERIC | Current |
| 71872-7135 | Epinephrine | Epinephrine | Medical Purchasing Solutions, LLC | NDA AUTHORIZED GENERIC | Current |
| 71872-7135 | Epinephrine | Epinephrine | Medical Purchasing Solutions, LLC | NDA AUTHORIZED GENERIC | Current |