Documents
Application Sponsors
| NDA 019257 | LEADIANT BIOSCI INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;ORAL | 1GM/10ML | 1 | CARNITOR | LEVOCARNITINE |
| 002 | SOLUTION;ORAL | 1GM/10ML | 1 | CARNITOR SF | LEVOCARNITINE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1986-04-10 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1989-01-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-05-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1990-04-25 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1995-05-12 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1995-10-17 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1997-01-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 1998-12-15 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2002-04-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2007-03-28 | N/A |
| LABELING; Labeling | SUPPL | 12 | AP | 2015-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 14 | AP | 2018-04-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 3 | Null | 14 |
| SUPPL | 4 | Null | 14 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 7 | Null | 14 |
| SUPPL | 8 | Null | 14 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 7 |
TE Codes
| 001 | Prescription | AA |
| 002 | Prescription | AA |
CDER Filings
LEADIANT BIOSCI INC
cder:Array
(
[0] => Array
(
[ApplNo] => 19257
[companyName] => LEADIANT BIOSCI INC
[docInserts] => ["",""]
[products] => [{"drugName":"CARNITOR","activeIngredients":"LEVOCARNITINE","strength":"1GM\/10ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"CARNITOR SF","activeIngredients":"LEVOCARNITINE","strength":"1GM\/10ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/17\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/018948s028,019257s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2015","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/018948s026,019257s012,020182s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2007","submission":"SUPPL-11","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018948s024,019257s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2007","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018948s024,019257s011lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2002","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/18948S22lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"CARNITOR","submission":"LEVOCARNITINE","actionType":"1GM\/10ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CARNITOR SF","submission":"LEVOCARNITINE","actionType":"1GM\/10ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2018-04-17
)
)