Reference Listed Drug Labeling Approved in November 2001

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Reference Listed Drug Labeling Supplements Approved in November 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.
Nov 1	COREG	letter		carvedilol tablets	20-297	S-007
	INDERIDE LA	letter	label	propranolol HCl/HCTZ extended-release capsules	19-059	S-016
	INDERIDE	letter	label	propranolol HCl/HCTZ tablets	18-031	S-030
Nov 5	TAMIFLU	letter	label	oseltamivir phosphate suspension oseltamivir phosphate capsules	21-246 21-087	S-004 S-009
Nov 7	REGLAN	letter	label	metoclopramide HCl solution metoclopramide HCl tablet metoclopramide HCl injection	18-821 17-854 17-862	S-020 S-041 S-048
Nov 9	MYCOBUTIN	letter	label	rifabutin capsules	50-689	S-013
Nov 14	LUPRON DEPOT	letter		leuprolide acetate injectable	20-011	S-022
	LUPRON DEPOT-3	letter		leuprolide acetate injectable	20-708	S-013
	PROSOL 20% SULFITE FREE	letter		amino acid injection	20-849	S-004
	ZOCOR	letter	label	simvastatin tablet	19-766	S-053
	ZOVIRAX	letter	label	acyclovir tablets acyclovir suspension acyclovir capsule	20-089 19-909 18-828	S-016 S-017 S-027
Nov 16	CALCIJEX	letter		calcitriol injection	18-874	S- 016
Nov 16	VIDEX	letter	label	didanosine tablets didanosine oral solution	20-155 20-154	S-027 S-036
Nov 20	DILANTIN DILANTIN-125	letter		phenytoin injection phenytoin suspension	10-151 8-762	S-034 S-026
Nov 21	CLEOCIN PHOSPHATE	letter	label	clindamycin injection	50-441	S-047
Nov 21	ROCEPHIN W/ DEXTROSE	letter		ceftriaxone injection	50-624	S-021
Nov 23	SINGULAIR	letter	label	montelukast sodium tablets	20-830	S-011
Nov 26	INAPSINE	letter		droperidol injection	16-796	S-039
	INDOCIN	letter		indomethacin suspension	18-332	S-023
	LITHIUM CARBONATE	letter		lithium carbonate capsules	17-812	S-017
	LITHIUM CITRATE	letter		lithium citrate syrup	18-421	S-016
Nov 27	VASERETIC	letter	label	enalapril maleate/HCTZ tablet	19-221	S-026
	VASOTEC	letter letter	label label	enalaprilat injection enalapril maleate tablets	19-309 18-998	S-023 S-058
	WYTENSIN	letter		guanabenz acetate tablets	18-587	S-023
Nov 28	ATACAND	letter		candesartan cilexetil tablets	20-838	S-016
Nov 28	ATACAND HCT	letter		candesartan cilexetil/HCTZ tablets	21-093	S-001
Nov 30	PRIMAXIN IM PRIMAXIN IV	letter	label label	imipenem/cilstatin sodium injection imipenem/cilstatin sodium injection	50-630 50-587	S-017 S-053
Nov 30	TIMOPTIC	letter	label	timolol maleate ophthalmic solution	18-086	S-056