Reference Listed Drug Labeling Approved in December 2000

Reference Listed Drug Labeling Approved in December 2000

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Approval Date	Product Name			Established Name	NDA No.	Supp.No.
Dec 1	CELEBREX	letter	label	celecoxib capsules	20-998	S-008
	CYTOVENE CYTOVENE IV	letter	label	ganciclovir tablets ganciclovir sodium for injection	20-460 19-661	S-010 S-024
	NASONEX	letter	label	mometasone furoate nasal suspension	20-762	S-009
Dec 4	CLARITIN	letter	label	loratadine syrup	20-641	S-007
Dec 6	SYMMETREL	letter	label	amantadine HCl tablets amantadine HCl syrup	16-023 18-101	S-035 S-007
Dec 8	ANTIZOL	letter	label	fomepizole injection	20-696	S-001
Dec 8	ZOFRAN	letter	label	ondansetron HCl injection in plastic container ondansetron HCl injection	20-403 20-007	S-010 S-031
Dec 11	IMITREX	letter	label	sumatriptan nasal solution (spray)	20-626	S-003
	MAXALT MAXALT-MLT	letter	label	rizatriptan tablets rizatriptan orally disintegrating tablets	20-864 20-865	S-004 S-005
	SANSERT	letter	label	methysergide maleate tablets	12-516	S-038
Dec 12	REVEX	letter	label	nalmefene HCl injection	20-459	S-002
Dec 13	ZOFRAN ZOFRAN ODT	letter	label	ondansetron HCl tablets ondansetron HCl oral solution ondansetron HCl orally disintegrating tablets	20-605 20-103 20-781	S-005 S-018 S-002
Dec 15	ZIAGEN	letter	label	abacavir sulfate tablets abacavir sulfate oral solution	20-977 20-978	S-005 S-002
Dec 15	GLUCOPHAGE	letter	label	metformin HCl tablets	20-357	S-019
Dec 18	LESCOL	letter	label	fluvastatin sodium	20-261	S-025
	POLYTRIM	letter	label	polymyxin B sulfate/trimethoprim sulfate ophth. sol.	50-567	S-016
	REBETOL	letter	label	interferon alfa-2b, recombinant inj/ribavirin capsules	20-903	S-004
Dec 19	AGENERASE	letter	label	amprenavir amprenavir oral solution	21-007 21-039	S-005 S-005
Dec 20	CELLCEPT	letter	label	mycophenolate mofetil capsules mycophenolate mofetil tablets mycophenolate mofetil oral solution	50-722 50-723 50-759	S-007 S-004 S-005
Dec 20	INTRALIPID 10%	letter	label	soybean oil injectable emulsion	17-643	S-060
Dec 26	XALATAN	letter	label	latanoprost ophthalmic solution	20-597	S-014
Dec 28	INTRALIPID 20%	letter	label	soybean oil injectable emulsion	18-449	S-027

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