Reference Listed Drug Labeling Approved in April 2001

Approval Date	Product Name	Links to Source Documents		Established Name	NDA No.	Supp.No.
Reference Listed Drug Labeling Supplements Approved in April 2001 Click on appropriate hyperlink below to view available source document in PDF format.
Apr 3	COMPAZINE	letter	label	prochlorperazine maleate tablets prochlorperazine maleate injection prochlorperazine maleate extended-release capsules prochlorperazine maleate suppositories prochlorperazine maleate extended-release capsules	10-571 10-742 11-000 11-127 21-019	S-095 S-065 S-084 S-061 S-001
	CRINONE	letter	label	progesterone gel 4%	20-701	S-007
	CRINONE	letter letter	label	progesterone gel 8%	20-756 20-756	S-008 S-009
	STELAZINE	letter	label	trifluperazine HCl tablets, injection,concentrate	11-552	S-112
	THORAZINE	letter	label	chlorpromazine HCl tablets,capsules,injection,syrup	11-120	S-086
Apr 4	CLIMARA	letter	label	estradiol transdermal system	20-375	S-014
	DROXIA	letter	label	hydroxyurea capsules	16-295	S-034
	HYDREA	letter	label	hydroxyurea capsules	16-295	S-034
Apr 5	CLIMARA	letter	label	estradiol transdermal system	20-375	S-016
	IMODIUM A-D	letter	label	loperamide tablets	19-860	S-018
	VIRACEPT	letter	label	nelfinavir mesylate tablets nelfinavir mesylate for oral suspension	20-778 20-779	S-014 S-032
Apr 6	CYSTAGON	letter	label	cysteamine bitartrate capsule	20-392	S-005
	DETROL	letter	label	tolterodine tartrate tablets	20-771	S-004
	FLUMADINE	letter	label	rimantadine HCl tablets rimantadine HCl syrup	19-649 19-650	S-006 S-004
Apr 9	CELONTIN	letter	label	methsuximide tablets	10-596	S-012
	DESFERAL	letter	label	deferoxamine mesylate injection	16-267	S-034
	DURAGESIC	letter	label	fentanyl transdermal system	19-813	S-030
	ZARONTIN	letter	label	ethosuximide capsules	12-380	S-025
Apr 11	DIASTAT	letter	label	diazepam rectal gel	20-648	S-002
	KLONOPIN	letter	label	clonazepam tablets	17-533	S-031
	SINEMET	letter	label	carbidopa/levodopa tablets	17-555	S-055
	UNIVASC	letter	label	moexipril HCl tablets	20-312	S-016
Apr 13	LAMISIL	letter	label	terbinafine HCl tablets	20-539	S-010
Apr 13	PAXIL	letter	label	paroxetine HCl tablets	20-031	S-026
Apr 16	NOROXIN	letter	label	norfloxacin tablets	19-384	S-039
Apr 17	ACCUPRIL	letter	label	quinapril HCl tablets	19-885	S-018
Apr 18	INFED	letter	label	iron dextran injection	17-441	S-161
Apr 18	TICLID	letter	label	ticlopidine hydrochloride tablets	19-979	S- 018
Apr 19	GLUCOPHAGE	letter	label	metformin HCl tablets	20-357	S-020
Apr 19	GLUCOPHAGE XR	letter	label	metformin HCL extended-release tablets	21-202	S-001
Apr 20	CORVERT	letter	label	ibutilide fumarate injection	20-491	S-003
Apr 23	ZYFLO	letter	label	zileuton tablets	20-471	S-008
Apr 24	VAGISTAT-1	letter	label	tioconazole vaginal ointment	20-676	S-001
Apr 25	PEPCID PEPCID RPD	letter	label	famotidine tablets famotidine orally disintegrating tablets famotidine oral suspension	19-462 20-752 19-527	S-029 S-004 S-023
Apr 25	PEPCID	letter	label	famotidine injection	19-510 20-249	S-027 S-010
Apr 26	MEVACOR	letter	label	lovastatin tablets	19-643	S-064
Apr 27	ACULAR	letter	label	ketorolac tromethamine ophthalmic solution	19-700	S-014
	AZELEX	letter	label	azelaic acid cream	20-428	S-013
	ACCOLATE	letter	label	zafirlukast tablets	20-547	S-014
	DETROL LA	letter	label	tolterodine extended-release capsules	21-228	S-001
	RELENZA	letter	label	zanamivir for inhalation	21-036	S-004
Apr 30	PARAPLATIN	letter	label	carboplatin for injection	19-880	S-016
Apr 30	XELODA	letter	label	capecitabine tablets	20-896	S-009