Reference Listed Drug Labeling Approved in July 2001

Reference Listed Drug Labeling Supplements Approved in July 2001 Click on appropriate hyperlink below to view available source document in PDF format.
Approval Date	Product name	Links to source documents		Established Name	NDA No.	Supp. No.
Jul 1	ESTROSTEP 21	letter	label	norethindrone acetate/ethinyl estradiol tablets	20-130	S-007
Jul 2	ACTOS	letter		pioglitazone HCl tablets	21-073	S-011
Jul 2	SANDOSTATIN SANDOSTATIN LAR	letter		octreotide acetate injection octreotide acetate injectable suspension	19-667 21-008	S-038 S-003
Jul 3	PROTONIX IV	letter		pantoprazole sodium for injection	20-988	S-004
Jul 9	NICOTROL	letter		nicotine inhalation system	20-385 20-714	S-003 S-007
Jul 11	ALLEGRA	letter	label	fexofenadine HCL capsules fexofenadine HCL tablets	20-625 20-872	S-011 S-007
Jul 11	CORDARONE	letter	label	amiodarone injection	20-377	S-005
Jul 12	COPAXONE	letter	label	glatiramer acetate for injection	20-622	S-015
	SULFAMYLON	letter		mafenide acetate USP	19-832	S-002
	ZINACEF	letter	label	cefuroxime Na for injection cefuroxime Na injection	50-558 50-643	S-049 S-010
Jul 13	BREVITAL SODIUM	letter		methohexytal sodium for injection	11-559	S-032
Jul 18	DILAUDID-HP	letter		hydromorphone HCl injection	19-034	S-008
Jul 18	OXYCONTIN	letter	label	oxycodone HCl tablets	20-553	S-022
Jul 19	BUSPAR	letter	label	buspirone HCl tablets	18-731	S-043
Jul 20	PROTONIX	letter	label	pantoprazole Na delayed release tablets	20-987	S-005
Jul 20	ZADITOR	letter	label	ketotifen fumarate ophthalmic solution	21-066	S-004
Jul 23	AKINETON	letter		biperiden HCl tablets biperiden lactate injection	12-003 12-418	S-021 S-009
Jul 23	EULEXIN	letter		flutamide capsules	18-554	S-023
Jul 24	TAMIFLU	letter	label	oseltamivir phosphate capsules oseltamivir phosphate oral suspension	21-087 21-246	S-008 S-003
Jul 25	GENOTROPIN	letter	label	somatropin for injection	20-280	S-031
	PROGRAF	letter	label	tacrolimus capsules tacrolimus injection	50-708 50-709	S-016 S-012
	REBETOL	letter	label	ribavirin capsules/interferon	20-903	S-016
Jul 26	MESTINON	letter	label	pyridostigamine tablets pyridostigamine extended-release tablets pyridostigamine syrup	9-829 11-665 15-193	S-011 S-015 S-018
	MESTINON	letter	label	pyridostigamine injection	9-830	S-010
	TRANSDERM SCOP	letter	label	scopalamine transdermal system	17-874	S-027
Jul 27	VIDEX	letter	label	didanosine tablets didanosine for oral solution	20-154 20-155	S-034 S-025
Jul 30	OCUFEN	letter	label	flurbiprofen sodium ophthalmic solution	19-404	S-014
Jul 31	ANAFRANIL	letter	label	clomipramine HCl capsules	19-906	S-009
	NAVANE	letter	label	thiotixene capsules thiotixene oral solution	16-584 16-758	S-055 S-016
	PAMELOR	letter	label	nortriptyline capsules	18-013	S-053

Labeling Review Branch Page

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