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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019500
Company: NOVARTIS

Products on NDA 019500

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019500

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.

Labels for NDA 019500

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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