Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018948
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 076858 ANDA REPOSITORY

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