Application 018948
- Type
- NDA
- Sponsor
- LEADIANT BIOSCI INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARNITOR | LEVOCARNITINE | TABLET;ORAL | 330MG | Yes | Yes |
| 002 | CARNITOR | LEVOCARNITINE | SOLUTION;ORAL | 1GM/10ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50383-172 | Levocarnitine | Levocarnitine | Hi-Tech Pharmacal Co., Inc. | NDA | Current |
| 50383-172 | Levocarnitine | Levocarnitine | Hi-Tech Pharmacal Co., Inc. | NDA | Current |
| 50383-172 | Levocarnitine | Levocarnitine | Hi-Tech Pharmacal Co., Inc. | NDA | Current |
| 50383-172 | Levocarnitine | Levocarnitine | Akorn | NDA | Current |
| 54482-144 | CARNITOR | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-144 | CARNITOR | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-144 | CARNITOR | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-144 | CARNITOR | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-144 | CARNITOR | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-144 | CARNITOR | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-144 | CARNITOR | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 57624 | ORIG | 2019-02-15 |
| 53759 | SUPPL | 2018-04-20 |
| 53734 | SUPPL | 2018-04-19 |
| 33671 | SUPPL | 2015-06-04 |
| 1149 | SUPPL | 2015-06-02 |
| 16127 | SUPPL | 2007-04-09 |
| 33670 | SUPPL | 2007-03-31 |
| 33669 | SUPPL | 2002-04-15 |
| 1148 | SUPPL | 2002-04-15 |
| 20170 | SUPPL | 1998-05-07 |