Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NARCAN | NALOXONE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NARCAN | NALOXONE HYDROCHLORIDE |
| 003 | INJECTABLE;INJECTION | 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NARCAN | NALOXONE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1971-04-13 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1975-04-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1975-04-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 1975-01-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 1975-06-05 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 1974-12-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 11 | AP | 1975-06-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 1975-09-24 | PRIORITY |
| LABELING; Labeling | SUPPL | 14 | AP | 1976-04-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 1976-04-06 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1978-10-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 1979-03-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1979-11-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1980-06-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1981-06-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1981-04-01 | PRIORITY |
| LABELING; Labeling | SUPPL | 22 | AP | 1981-09-30 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1981-05-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1981-05-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1982-05-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 27 | AP | 1982-07-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1982-06-14 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1983-06-23 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 1992-05-29 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1983-11-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1983-11-17 | PRIORITY |
| LABELING; Labeling | SUPPL | 34 | AP | 1985-07-23 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1984-10-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1984-09-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1984-09-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1984-09-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1986-06-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1986-06-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1986-06-04 | PRIORITY |
| LABELING; Labeling | SUPPL | 46 | AP | 1986-06-04 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 47 | AP | 1987-02-26 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 48 | AP | 1987-10-20 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 49 | AP | 1987-12-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 50 | AP | 1995-06-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 51 | AP | 1995-03-20 | PRIORITY |
| LABELING; Labeling | SUPPL | 52 | AP | 2002-02-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 53 | AP | 1996-09-06 | PRIORITY |
| LABELING; Labeling | SUPPL | 54 | AP | 2002-02-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 55 | AP | 2002-04-16 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 56 | AP | 2002-01-15 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 57 | AP | 2002-10-25 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | 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 | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 46 | Null | 0 |
| SUPPL | 47 | Null | 0 |
| SUPPL | 48 | Null | 0 |
| SUPPL | 49 | Null | 0 |
| SUPPL | 50 | Null | 0 |
| SUPPL | 51 | Null | 0 |
| SUPPL | 52 | Null | 0 |
| SUPPL | 53 | Null | 0 |
| SUPPL | 54 | Null | 0 |
| SUPPL | 55 | Null | 0 |
| SUPPL | 56 | Null | 0 |
| SUPPL | 57 | Null | 0 |
CDER Filings
ADAPT
cder:Array
(
[0] => Array
(
[ApplNo] => 16636
[companyName] => ADAPT
[docInserts] => ["",""]
[products] => [{"drugName":"NARCAN","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"0.4MG\/ML **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":"NARCAN","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"0.02MG\/ML **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":"NARCAN","activeIngredients":"NALOXONE HYDROCHLORIDE","strength":"1MG\/ML **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] => [{"actionDate":"02\/11\/2002","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/016636s052s054lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2002","submission":"SUPPL-52","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/016636s052s054lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NARCAN","submission":"NALOXONE HYDROCHLORIDE","actionType":"0.4MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NARCAN","submission":"NALOXONE HYDROCHLORIDE","actionType":"0.02MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NARCAN","submission":"NALOXONE HYDROCHLORIDE","actionType":"1MG\/ML **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] => 2002-02-11
)
)