Application Sponsors
Marketing Status
| Discontinued | 003 |
| Discontinued | 004 |
| Discontinued | 005 |
| Discontinued | 007 |
| Discontinued | 008 |
Application Products
| 003 | INJECTABLE;INJECTION | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CITANEST | PRILOCAINE HYDROCHLORIDE |
| 004 | INJECTABLE;INJECTION | 1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CITANEST | PRILOCAINE HYDROCHLORIDE |
| 005 | INJECTABLE;INJECTION | 2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CITANEST | PRILOCAINE HYDROCHLORIDE |
| 007 | INJECTABLE;INJECTION | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | CITANEST PLAIN | PRILOCAINE HYDROCHLORIDE |
| 008 | INJECTABLE;INJECTION | 0.005MG/ML;4% | 0 | CITANEST FORTE | EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1965-11-18 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1976-03-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 1976-03-03 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1979-04-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 1979-04-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 1979-08-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1981-05-08 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1981-08-31 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1982-07-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 19 | AP | 1982-07-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 20 | AP | 1981-08-31 | PRIORITY |
| LABELING; Labeling | SUPPL | 21 | AP | 1985-03-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1985-03-22 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1982-06-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 24 | AP | 1986-08-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 25 | AP | 1986-03-21 | PRIORITY |
| LABELING; Labeling | SUPPL | 26 | AP | 1987-03-11 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 1997-05-09 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1996-05-31 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2000-12-01 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
CDER Filings
ASTRAZENECA
cder:Array
(
[0] => Array
(
[ApplNo] => 14763
[companyName] => ASTRAZENECA
[docInserts] => ["",""]
[products] => [{"drugName":"CITANEST","activeIngredients":"PRILOCAINE HYDROCHLORIDE","strength":"3% **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":"CITANEST","activeIngredients":"PRILOCAINE 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":"CITANEST","activeIngredients":"PRILOCAINE HYDROCHLORIDE","strength":"2% **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":"CITANEST FORTE","activeIngredients":"EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE","strength":"0.005MG\/ML;4%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CITANEST PLAIN","activeIngredients":"PRILOCAINE HYDROCHLORIDE","strength":"4% **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":"CITANEST","submission":"PRILOCAINE HYDROCHLORIDE","actionType":"3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CITANEST","submission":"PRILOCAINE 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":"CITANEST","submission":"PRILOCAINE HYDROCHLORIDE","actionType":"2% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CITANEST FORTE","submission":"EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE","actionType":"0.005MG\/ML;4%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CITANEST PLAIN","submission":"PRILOCAINE HYDROCHLORIDE","actionType":"4% **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
)
)