Reference Listed Drug Labeling Approved in September 2001

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Reference Listed Drug Labeling Supplements Approved in September 2001 Click on appropriate hyperlink below to view available source document in PDF format.
Approval Date	Trade Name			Active Ingredient(s)/Dosage Form	NDA No.	Supp. No.
Sep 4	PROGRAF	letter	label	tacrolimus capsules tacrolimus injection	S- 013 S- 010	50-708 50-709
	THALOMID	letter	label	thalidomide capsules	S-014	20-785
	VERSED	letter		midazolam HCl injection	S-038	18-654
Sep 5	ANDROGEL	letter	label	testosterone gel	S-003	21-015
Sep 5	GLUCOTROL XL	letter		glipizide extended-release tablets	S-006	20-329
Sep 6	LUVOX	letter	label	fluvoxamine maleate tablets	S-023	20-243
Sep 6	SEROSTIM	letter		somatropin for injection	S-016	20-604
Sep 7	XELODA	letter	label	capecitabine tablet	S-011	20-896
Sep 10	VIDEX	letter	label	didanosine for oral solution didanosine tablets	S-026 S-035	20-155 20-154
Sep 12	RETROVIR	letter	label	zidovudine injection	S-016	19-951
Sep 13	CYTOMEL	letter		liothyronine Na tablets	S-045	10-379
Sep 16	ISORDIL	letter	label	isosorbide dinitrate tablets	S-044	12-940
Sep 18	LEXXEL	letter	label	felodipine/enalapril maleate extended release tablet	S-008	20-668
	MIDAMOR	letter	label	amiloride HCl tablet	S-023	18-200
	MODURETIC 5-50	letter	label	amiloride HCl/HCTZ tablet	S-036	18-201
Sep 21	DETROL LA	letter	label	tolterodine tartrate extended-release capsules	S-002	21-228
Sep 25	AGGRASTAT	letter		tirofiban HCl injection	S-007 S-008	20-913 20-912
	FORADIL	letter	label	formoterol fumarate for inhalation	S-002	20-831
	LESCOL LESCOL XL	letter	label	fluvastatin sodium tablets fluvastatin sodium exteneded-release tablets	S-030 S-002	20-261 21-192
Sep 26	AVALIDE	letter	label	irbesartan/HCTZ tablets	S-013	20-758
	AVAPRO	letter	label	irbesartan tablets	S-011	20-757
	ISORDIL	letter	label	isosorbide dinitrate tablet	S-044	12-093
Sep 27	LORABID	letter		loracarbef oral suspension	S-022	50-667
Sep 28	ISOPTIN SR	letter		verapamil HCL extended-release tablets	S-026	19-152
Reference Listed Drug Efficacy Supplements Approved in September 2001 Click on appropriate hyperlink below to view available source document in PDF format.
Approval Date	Trade Name			Active Ingredient(s)/Dosage Form	NDA No.	Supp. No.
Sep 21	LUPRON DEPOT	letter	label	leuprolide acetate for depot suspension	S-021	20-011
	Efficacy Claim: For the use of Lupron Depot 3.75 mg monthly with norethindron acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms
	LUPRON DEPOT-3	letter	label	leuprolide acetate for depot suspension	S-011	20-708
	Efficacy Claim: For the use of Lupron Depot 3-Month 11.25 mg with norethindron acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms
Sep 7	XELODA	letter	label	capecitabine tablet	S-011	20-896
Sep 7	Efficacy Claim: Provides for the use of Xeloda in combination with Taxotere for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy
Original NDAs Approved in September 2001 Click on appropriate hyperlink below to view available source document in PDF format.
Approval Date	Trade Name			Active Ingredient(s)/Dosage Form	NDA No.
Sep 4	TRICOR	letter	label	fenofibrate tablets	21-203
Sep 4	Indication(s): For adjunctive therapy to diet to reduce elevated LDL-C, Total_C, triglycerides and Apo-B and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed lipidemia (Fredrickson Types Iia and IIb), and as adjuctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia)
Sep 25	FORADIL	letter	label	formoterol fumarate inhalation powder	21-279
Sep 25	Indication(s): For the long-term, twice-daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease including chronic bronchitis and emphysema