Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018948
Company: LEADIANT BIOSCI INC
Company: LEADIANT BIOSCI INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARNITOR | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| CARNITOR | LEVOCARNITINE | 1GM/10ML | SOLUTION;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/27/1985 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018948Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/17/2018 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018948Orig1s028,019257Orig1s014ltr.pdf | |
| 05/29/2015 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018948Orig1s026,019257Orig1s012,020182Orig1s013ltr.pdf | |
| 02/22/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2007 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018948s024,019257ltr.pdf | |
| 04/15/2002 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18948s22ltr.pdf | |
| 12/15/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/21/1997 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1997 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1996 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/20/1995 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/14/1992 | SUPPL-16 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018948a_s016_071492.pdf |
| 07/22/1992 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/14/1992 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/13/1994 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/16/1992 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 12/07/1989 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/07/1989 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/22/1989 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/16/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/27/1988 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/17/2018 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf | |
| 05/29/2015 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018948s026,019257s012,020182s013lbl.pdf | |
| 03/28/2007 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018948s024,019257s011lbl.pdf | |
| 04/15/2002 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18948S22lbl.pdf |
CARNITOR
TABLET;ORAL; 330MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARNITOR | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | Yes | AB | 018948 | LEADIANT BIOSCI INC |
| LEVOCARNITINE | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | No | AB | 216384 | NOVITIUM PHARMA |
| LEVOCARNITINE | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | No | AB | 076858 | RISING |