Reference Listed Drug Labeling Approved in December 2001

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Reference Listed Drug Labeling Supplements Approved in December 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.
Dec 3	FLUDARA	letter	label	fludarabine phosphate for injection	20-038	S-019
Dec 3	TIMOPTIC-XE	letter	label	timolol maleate ophthalmic solution	20-330	S-015
Dec 4	SERZONE	letter	label	nefazodone hydrochloride tablets	20-152	S-028
Dec 6	DESOXYN	letter	label	methamphetamine HCl tablets	5-378	S-020
Dec 7	DURAMORPH PF	letter		morphine sulfate injection	18-565	S-009
Dec 7	TIMOPTIC	letter	label	timolol maleate ophthalmic solution	19-463	S-022
Dec 8	ALDARA	letter	label	imiquimod cream	20-723	S-001
Dec 8	PROPECIA	letter	label	finasteride tablets	20-788	S-003
Dec 9	CUTIVATE	letter	label	fluticasone proprionate ointment	19-957	S-009
Dec 10	COLGATE TOTAL	letter		sodium fluoride/triclosan dental paste	20-231	S-022
Dec 12	ATIVAN	letter	label	lorazepam injection	18-140	S-027
Dec 12	TABLOID	letter		thioguanine tablets	12-429	S-017
Dec 14	LOTENSIN LOTENSIN HCT	letter letter	label	benazepril HCl tablets benazepril/HCTZ tablets	19-851 20-033	S-021 S-018
Dec 18	CORDARONE	letter	label	amiodarone HCl tablets	18-972	S-021
	LEVAQUIN	letter	label	levofloxacin tablets	20-635	S-020
	LEVAQUIN	letter	label	levofloxacin injection	20-634	S-022
	MS CONTIN	letter	label	morphine sulfate sustained-release tablets	19-516	S-016
Dec 20
Dec 20	CAVERJECT	letter	label	alprostadil injection	20-755	S-004
Dec 21	ETOPOPHOS	letter		etoposide phosphate injection	20-457	S-002
Dec 28	REBETOL	letter	label	ribavirin capsules	20-903	S-013
Dec 31	ACCUTANE	letter	label	isotretinoin capsules	18-662	S-045
Dec 31	PULMICORT	letter	label	budesonide inhalation powder	20-441	S-012
Reference Listed Drug Efficacy Supplements Approved in December 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.
Dec 14	PAXIL	letter	label	paroxetine HCl tablets	20-031	S-029
	Efficacy claim: For the treatment of posttraumatic stress disorder
	ZITHROMAX	letter	label	azithromycin for oral suspension	50-710	S-009
	Efficacy claim: For the teatment of acute otits media with 1-day and 3-day dosing regimens
Dec 18	PRAVACHOL	letter	label	pravastatin sodium tablets	19-898	S-009
Dec 18	Efficacy claim: New dosing regimen (80 mg once daily)
Dec 20	ALPHAGAN	letter	label	brimonidine tartrate ophthalmic solution	20-613	S-018
Dec 20	Efficacy claim: For the prevention of post-operative IOP elevations in patients undergoing argon laser trabeculoplasty (ALT)