Application 020182
- Type
- NDA
- Sponsor
- LEADIANT BIOSCI INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARNITOR | LEVOCARNITINE | INJECTABLE;INJECTION | 200MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54482-147 | Carnitor | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-147 | Carnitor | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-147 | Carnitor | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-147 | Carnitor | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-147 | Carnitor | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
| 54482-147 | Carnitor | levocarnitine | Leadiant Biosciences, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 53762 | SUPPL | 2018-04-20 |
| 53736 | SUPPL | 2018-04-19 |
| 34349 | SUPPL | 2015-06-04 |
| 24542 | SUPPL | 2015-06-02 |
| 24541 | SUPPL | 2002-04-15 |
| 12303 | SUPPL | 2002-04-15 |
| 20527 | SUPPL | 1999-12-15 |
| 12302 | SUPPL | 1999-12-15 |
| 2146 | SUPPL | 1999-12-15 |