Reference Listed Drug Labeling Approved in October 2001

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Reference Listed Drug Labeling Supplements Approved in October 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.
Oct 1	BETAPACE	letter		sotalol HCl tablets	19-865	S-010
	BETAPACE AF	letter	label	sotalol HCl tablets	21-151	S-003
	CEFZIL	letter	label	cefprozil tablets cefprozil oral solution	50-664 50-665	S-020 S-022
	DANTRIUM	letter		dantrolene sodium for injection	18-264	S-022
	PROPYLTHIOURACIL	letter		propylthiouracil tablets	6-188	S-019
Oct 2	GEREF	letter		sermorelin acetate for injection	19-863	S-006
Oct 2	NAVELBINE	letter	label	vinorelbine tartrate injection.	20-388	S-010
Oct 3	COZAAR HYZAAR	letter	label label	losartan potassium tablets losartan potassium/HCTZ tablets	20-386 20-387	S-022 S-018
Oct 3	INFUVITE PEDIATRIC	letter	label	multiple vitamins for infusion	21-265	S-001
Oct 4	FIORICET W/ CODEINE	letter		codeine/butalbital/APAP/caffeine capsules	20-232	S-012
	FIORINAL W/CODEINE	letter		codeine/butalbitall/aspirin/caffeine capsules	19-429	S-016
	PONSTEL	letter		mefenamic acid capsules	15-034	S-034
Oct 5	RETROVIR	letter	label	ziodovudine capsules zidovudine tablets	19-655 20-518	S-036 S-008
Oct 10	MYAMBUTOL	letter	label	ethambutol tablets	16-320	S-056
Oct 11	RELAFEN	letter	label	nabumetone tablets	19-583	S-019
Oct 11	TORADOL	letter		ketoralac tromethamine injection	19-645	S-009
Oct 12	CECLOR	letter		cefaclor suspension	50-522	S-023
	MIRENA	letter		levonorgestrel-releasing intrauterine system	21-225	S-002
	ZINACEF	letter	label	cefuroxime for injection cefuroxime injection	50-558 50-643	S-050 S-011
Oct 16	SUSTIVA	letter	label	efavirenz capsules	20-972	S-013
Oct 16	ZERIT	letter	label	stavudine capsules stavudine oral solution	20-412 20-413	S-015 S-006
Oct 18	TRILAFON	letter	label	perphenazine tablets perphenazine injection	10-775 11-213	S-030 S-022
Oct 22	MEVACOR	letter	label	lovastatin tablets	19-643	S-069
Oct 23	PARNATE	letter	label	tranylcypromine sulfate tablets	12-342	S-053
Oct 24	MAXAQUIN	letter	label	lomefloxacin tablets	20-013	S-008
	REBETOL	letter	label	ribavirin capsules	20-903	S-014
	TONOCARD	letter	label	tocainide HCl tablets	18-257	S-029
Oct 26	GLUCOTROL XL	letter	label	glipizide extended-release tablets	20-329	S-013
	SINGULAIR	letter letter		montelukast sodium tablets montelukast sodium tablets (chewable)	20-829 20-830	S-014 S-016
	THYROGEN	letter	label	thyrotropin alfa for injection	20-898	S-005
Oct 30	ACCUTANE	letter	label	isotretinoin capsules	18-662	S-044
	ANSAID	letter		flurbiprofen tablets	18-766	S-011
	CLINORIL	letter	label	sulindac tablets	17-911	S-066
	DARVOCET-N 100	letter		propoxyphene napsylate/acetaminophen tablets	17-122	S-047
	ORTHO-PREFEST	letter		estradiol/estradiol/norgestimate tablets	21-040	S-008
	PRILOSEC	letter	label	omeprazole capsules	19-810	S-073
Oct 31	CYKLOKAPRON	letter		tranexamic acid injection	19-281	S-015
	INDOCIN	letter	label	indomethacin capsules indomethacin suppositories indomethacin oral suspension	16-059 17-814 18-332	S-088 S-028 S-021
	REBETOL	letter	label	ribavirin capsules	20-903	S-010
	SYNALGOS-DC	letter		dihydrocodeine bitartrate capsules	11-483	S-015
	TEQUIN	letter	label	gatifloxacin tablets gatifloxacin HCl injection	21-061 21-062	S-012 S-012
	VOLTAREN CATAFLAM VOLTAREN-XR	letter	label	diclofenac sodium delayed-release tablets diclofenac potassium tablets diclofenac sodium extended-release tablets	19-201 20-142 20-254	S-023 S-006 S-002
Reference Listed Drug Efficacy Supplements Approved in October 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.
Oct 3	DIPROSONE	letter letter letter	label label label	betamethasone dipropionate cream betamethasone dipropionate ointment betamethasone dipropionate lotion	17-536 17-691 17-781	S-024 S-024 S-022
	Efficacy Claim: For patients with atopic dermatitis, 12 years of age and younger
	DIPROLENE AF	letter	label	betamethasone dipropionate cream	19-555	S-016
	Efficacy Claim: For patients with atopic dermatitis, 12 years of age and younger
	LOTRISONE	letter	label	clotrimazole/betamethasone dipropionate cream	18-827	S-022
	Efficacy Claim: For patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum
Oct 10	DERMA-SMOOTHE/FS	letter	label	fluocinolone acetonide topical oil	19-452	S-017
Oct 10	Efficacy Claim: For use in pediatric patients 2 years and older for the treatment of atopic dermatitis
Oct 11	TAZORAC	letter	label	tazarotene cream	21-184	S-001
Oct 11	Efficacy Claim: For acne vulgaris
Oct 12	ZOLOFT	letter	label	sertraline HCl tablets sertraline HCl oral concentrate	19-839 20-990	S-033 S-001
	Efficacy Claim: For the treatment of pediatric obsessive compulsive disorder (OCD)
	TEQUIN	letter	label	gatifloxacin tablets gatifloxacin HCl injection	21-061 21-062	S-007 S-008
	Efficacy Claim:For the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration
Oct 18	CELEBREX	letter	label	celecoxib capsules	20-998	S-010
Oct 18	Efficacy Claim: For the management of acute pain in adults and the treatment of primary dysmenorrhea
Oct 19	PROTONIX IV	letter	label	pantoprazole sodium for injection	20-988	S-003
Oct 19	Efficacy Claim: For the treatment of pathological hypersecretion associated with Zollinger-Ellison Syndrome (ZES)
Oct 26	RHINOCORT	letter		budesonide nasal solution	20-746	S-004
Oct 26	Efficacy Claim: For the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older