Reference Listed Drug Labeling Approved in May 2000

Reference Listed Drug Labeling Approved in May 2000

Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes. Click on the product name to view the approved labeling changes in Adobe Acrobat format.

Tradename	Active Ingredient	Dosage Form	NDA #	Supp#	May
ACCUTANE	isotretinoin	capsule	18-662	S-038	1
ACCUTANE	isotretinoin	capsule	18-662	S-039	1
ACCUTANE	isotretinoin	capsule	18-662	S-040	1
ZOMIG	zolmitriptan	tablet	20-768	S-003	1
BUTISOL	butabarbital Na	tablet	00-793	S-020	2
HALDOL	haloperidol	tablet	15-921	S-075	2
HALDOL	haloperidol lactate	oral solution	15-922	S-065	2
HALDOL	haloperidol lactate	injection	15-923	S-066	2
XANAX	alprazolam	tablet	18-276	S-035	2
HALDOL	haloperidol decanoate	injection	18-701	S-043	2
SINEMET CR	carbidopa/levodopa	extended-release tablet	19-856	S-015	2
RAPAMUNE	sirolimus	oral solution	21-083	S-002	3
AVELOX	moxifloxacin HCl	tablet	21-085	S-001	4
NORVIR	ritonavir	capsules	20-659	S-023	8
NORVIR	ritonavir	oral solution	20-945	S-004	8
AVAPRO	irbesartan	tablet	20-757	S-015	9
AVALIDE	HCTZ/irbesartan	tablet	20-758	S-016	9
ALOPRIM	allopurinol Na	for injection	20-298	S-001	12
NAVELBINE	vinorelbine tartrate	injection	20-388	S-009	12
REQUIP	ropinirole HCl	tablet	20-658	S-007	15
ALEVE COLD AND SINUS	naproxen Na/ pseudoephedrine HCl	extended-release tablet	21-076	S-001	15
DEPAKENE	valproic acid	capsule	18-081	S-029	16
DEPAKENE	valproic acid	syrup	18-082	S-022	16
NORDITROPIN	somatropin	for injection	19-721	S-006	16
IOPIDINE	apraclonidine	ophthalmic solution	20-258	S-011	16
ESTRING	estradiol	vaginal ring	20-472	S-001	16
AMOXIL	amoxicillin	tablet	50-754	S-002	16
AMOXIL	amoxicillin	for oral suspension	50-760	S-001	16
AMOXIL	amoxicillin	tablet (chewable)	50-761	S-001	16
NORPACE	disopyramide phosphate	capsule	17-447	S-055	17
NORPACE CR	disopyramide phosphate	extended-release capsule	18-655	S-033	17
TROVAN	trovafloxacin mesylate	tablet	20-759	S-008	17
TROVAN PRESERVATIVE FREE	alatrofloxacin mesylate	injection	20-760	S-006	17
ROMAZICON	flumazenil	injection	20-073	S-010	22
MERREM I.V.	meropenem	for injection	50-706	S-005	23
TALWIN	pentazocine lactate	injection	16-194	S-062	24
NUROMAX	doxacurium Cl	injection	19-946	S-006	30

FDA/Center for Drug Evaluation and Research
Last Updated:January 06, 2006
Originator: OPS/OGD
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