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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020191
Company: NOVARTIS

Products on NDA 020191

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOMIDE	LODOXAMIDE TROMETHAMINE	EQ 0.1% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020191

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/1993	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2003	SUPPL-18	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20191slr018_alomide_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20191slr018ltr.pdf
12/04/2002	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/2002	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
03/16/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/2000	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/17/1999	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
09/28/1999	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
04/07/1999	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/05/1999	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/11/1999	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
08/04/1998	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
03/31/1998	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/09/1997	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/17/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
11/01/1995	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
11/01/1995	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/1995	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020191

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2003	SUPPL-18	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20191slr018_alomide_lbl.pdf

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