Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019500
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LAMPRENE CLOFAZIMINE 100MG CAPSULE;ORAL Discontinued None No No
LAMPRENE CLOFAZIMINE 50MG CAPSULE;ORAL Discontinued None Yes 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
12/15/1986 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/pre96/019500Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/31/2019 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019500s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019500Orig1s014ltr.pdf
07/08/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019500s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019500Orig1s013ltr.pdf
06/11/2003 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19500slr010_lamprene_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19500slr010ltr.pdf
04/12/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/20/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/13/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/16/1998 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/12/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/05/1995 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/20/1995 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1989 SUPPL-2 Labeling

Label is not available on this site.

09/22/1988 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/31/2019 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019500s014lbl.pdf
07/08/2016 SUPPL-13 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019500s013lbl.pdf
06/11/2003 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19500slr010_lamprene_lbl.pdf

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