Reference Listed Drug Labeling Approved in May 2001

Reference Listed Drug Labeling Supplements Approved in May 2001 Click on appropriate hyperlink below to view available source document in PDF format.
Approval Date	Product Name	Links to Source Documents	Established Name	NDA No.	Supp. No.

May 1	FLOMAX	letter	label	tamsulosin HCl capsules	20-579	S-007
May 1	PREVACID	letter	label	lansoprazole delayed-release capsules	20-406	S-038
May 2	EFFEXOR EFFEXOR XR	letter	label	venlafaxine HCl tablets venlafaxine HCl extended-release capsules	20-151 20-699	S-018 S-016
May 3	BUSPAR	letter	label	buspirone HCl tablets	18-731	S-045
	INDERIDE LA 80/50	letter	label	propranolol HCl/HCTZ extended-release capsules	19-059	S-017
	INDERIDE-80/25	letter	label	propranolol HCl/HCTZ tablets	18-031	S-031
May 7	TOBRASONE	letter	label	tobramycin/fluorometholone acetate ophthalmic suspension	50-628	S-001
May 8	METHOTREXATE	letter	label	methotrexate injection methotrexate tablets	11-719 08-085	S-100 S-051
May 9	AGENERASE	letter	label	amprenavir capsules amprenavir oral solution	21-007 21-039	S-009 S-008
	SPORANOX	letter letter letter	label label label	itraconazole capsules itraconazole oral solution itraconazole injection	20-083 20-657 20-966	S-025 S-004 S-004
	ZANTAC injection	letter	label	ranitidine HCl injection ranitidine HCl injection	19-090 19-593	S-044 S-032
	ZANTAC	letter	label	ranitidine HCl syrup ranitidine HCl tablets (effervescent) ranitidine HCl tablets ranitidine HCl capsules	19-675 20-251 18-703 20-095	S-024 S-010 S-060 S-012
May 10	MERETEK UBT KIT	letter	label	13C-urea	20-586	S-004
May 11	AGENERASE	letter	label	amprenavir capsules amprenavir oral solution	21-007 21-039	S-006 S-006
May 11	LORABID	letter	label	loracarbef oral suspension loracarbef capsules	50-667 50-668	S-020 S-022
May 14	ADVIL COLD AND SINUS	letter	label	ibuprofen/pseudoephedrine HCl tablets	19-771	S-018
May 14	BETAGAN	letter	label	levobunolol HCL ophthalmic solution	19-219 19-814	S-019 S-011
May 15	ANTAGON	letter	label	ganirelix acetate injection	21-057	S-002
May 15	REVIA	letter	label	naltrexone HCl tablets	18-932	S-015
May 16	IVY BLOCK	letter	label	bentoquatam topical solution	20-532	S-008
May 16	RESCRIPTOR	letter	label	delavirdine mesylate tablets	20-705	S-008
May 17	AVELOX	letter	label	moxifloxacin tablets	21-085	S-005
	ORLAAM	letter	label	levomethadyl acetate HCl oral solution	20-315	S-009
	SEREVENT	letter	label label	salmeterol xinafoate inhalation aerosol salmeterol xinafoate inhalation powder	20-236 20-692	S-023 S-015
	VERSED	letter	label	midazolam HCl syrup	20-942	S-004
May 18	AQUAMEPHYTON	letter	label	phytonadione injection	12-223	S-036
May 21	BAYCOL	letter	label	cerivastatin sodium tablets	20-740	S-019
	INOMAX	letter	label	nitric oxide for inhalation	20-845	S-001
	PROTONIX	letter	label	pantoprazole sodium delayed-release tablets	20-987	S-004
May 22	COGENTIN	letter	label	benztropine mesylate tablets benztropine mesylate injection	09-193 12-015	S-037 S-023
May 22	MOBAN	letter	label	molindone tablets molindone oral solution	17-111 17-938	S-055 S-022
May 23	ADVIL COLD AND SINUS	letter	label	ibuprofen/pseudoephedrine HCl tablets	19-771	S-020
May 25	LAMICTAL LAMICTAL CD	letter	label	lamictal tablets lamictal tablets (chewable,dispersible)	20-241 20-764	S-011 S-005
May 25	MYLOTARG	letter	label	gemtuzumab ozogamycin for injection	21-174	S-004
May 26	AVAPRO	letter	label	irbesartan tablets	20-757	S-014
May 29	ZANTAC 75	letter	label	ranitidine HCl tablets	20-520	S-010
May 30	ZOVIRAX	letter	label	acyclovir ointment	18-604	S-018
May 31	DOBUTAMINE	letter	label	dobutamine HCL/dextrose injection	20-255	S-008

FDA/Center for Drug Evaluation and Research
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