Application Sponsors
Marketing Status
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 006 |
| Discontinued | 007 |
Application Products
| 003 | INJECTABLE;INJECTION | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DURANEST | ETIDOCAINE HYDROCHLORIDE |
| 004 | INJECTABLE;INJECTION | 0.005MG/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DURANEST | EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE |
| 005 | INJECTABLE;INJECTION | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DURANEST | ETIDOCAINE HYDROCHLORIDE |
| 006 | INJECTABLE;INJECTION | 0.005MG/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DURANEST | EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE |
| 007 | INJECTABLE;INJECTION | 0.005MG/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | DURANEST | EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1976-08-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1982-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 1982-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 1987-01-29 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1982-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 1985-08-07 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 1986-03-06 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 1987-04-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1990-10-04 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 1999-03-02 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1996-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 1999-03-02 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 17751
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"DURANEST","activeIngredients":"ETIDOCAINE HYDROCHLORIDE","strength":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURANEST","activeIngredients":"EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE","strength":"0.005MG\/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURANEST","activeIngredients":"ETIDOCAINE HYDROCHLORIDE","strength":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURANEST","activeIngredients":"EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE","strength":"0.005MG\/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"DURANEST","activeIngredients":"EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE","strength":"0.005MG\/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"DURANEST","submission":"ETIDOCAINE HYDROCHLORIDE","actionType":"0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURANEST","submission":"EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE","actionType":"0.005MG\/ML;0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURANEST","submission":"ETIDOCAINE HYDROCHLORIDE","actionType":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURANEST","submission":"EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE","actionType":"0.005MG\/ML;1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"DURANEST","submission":"EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE","actionType":"0.005MG\/ML;1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)