Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AQUAMEPHYTON | PHYTONADIONE |
| 002 | INJECTABLE;INJECTION | 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | AQUAMEPHYTON | PHYTONADIONE |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 1960-06-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1976-09-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1979-09-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1980-11-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1981-11-03 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1981-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 1986-08-19 | |
| LABELING; Labeling | SUPPL | 22 | AP | 1982-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1984-10-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1985-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 1990-04-26 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1991-06-28 | |
| LABELING; Labeling | SUPPL | 27 | AP | 1995-04-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1995-06-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1995-12-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1996-06-25 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1996-12-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1996-12-06 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 1997-01-14 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1998-05-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1998-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2001-05-18 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 2001-08-16 | STANDARD |
| LABELING; Labeling | SUPPL | 38 | AP | 2003-02-27 | STANDARD |
| LABELING; Labeling | SUPPL | 39 | AP | 2003-06-04 | STANDARD |
| LABELING; Labeling | SUPPL | 40 | AP | 2017-05-25 | STANDARD |
| LABELING; Labeling | SUPPL | 41 | AP | 2018-03-07 | STANDARD |
| LABELING; Labeling | SUPPL | 42 | AP | 2018-11-23 | STANDARD |
Submissions Property Types
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 28 | Null | 0 |
| SUPPL | 29 | 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 | 37 | Null | 0 |
| SUPPL | 40 | Null | 7 |
| SUPPL | 41 | Null | 33 |
| SUPPL | 42 | Null | 15 |
CDER Filings
TELIGENT
cder:Array
(
[0] => Array
(
[ApplNo] => 12223
[companyName] => TELIGENT
[docInserts] => ["",""]
[products] => [{"drugName":"AQUAMEPHYTON","activeIngredients":"PHYTONADIONE","strength":"10MG\/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":"AQUAMEPHYTON","activeIngredients":"PHYTONADIONE","strength":"1MG\/0.5ML **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":"11\/23\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/012223s042lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/012223s042lbl.pdf\"}]","notes":""},{"actionDate":"03\/07\/2018","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/012223s041lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2017","submission":"SUPPL-40","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/012223s040lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2003","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/012223Orig1s039Lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"AQUAMEPHYTON","submission":"PHYTONADIONE","actionType":"10MG\/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":"AQUAMEPHYTON","submission":"PHYTONADIONE","actionType":"1MG\/0.5ML **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] => 2018-11-23
)
)