	Home : FDA Drug Database : Abitrexate : FDA Information : Reference Listed Drug Labeling Approved in October Reference Listed Drug Labeling Approved in October

Reference Listed Drug Labeling Approved in October 1999

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.

Product Name	Established Name	NDA No.	Supp.No.	Firm	Date
TOPAMAX	Topiramate Tablets	20-505	S-003	Johnson RW	1-Oct-1999
TOPAMAX SPRINKLE	Topiramate Capsules	20-844	S-004	Johnson RW	1-Oct-1999
LUPRON DEPOT	Leuprolide Acetate For Injectable Susp	19-732	S-015	Tap Holdings	4-Oct-1999
CHEMET	Succimer Capsules	19-998	S-011	Sanofi Pharms	5-Oct-1999
LOVENOX	Enoxaparin Sodium Injection	20-164	S-031	Rhone Poulenc Rorer	5-Oct-1999
PERMAX	Pergolide Mesylate Tablets	19-385	S-026	Eli Lilly	6-Oct-1999
EXCEDRIN (MIGRAINE)	Acetaminophen/Aspirin/Caffeine Tablets	20-802	S-002	Bristol Myers	7-Oct-1999
PROZAC	Fluoxetine HCl Capsules	18-936	S-052	Lilly Res Labs	7-Oct-1999
PROZAC	Fluoxetine HCl Oral Solution	20-101	S-024	Eli Lilly	7-Oct-1999
GoLYTELY	PEG-3350 and electrolytes for oral sol.	19-011	S-013	Braintree Labs	7-Oct-1999
NuLYTELY	PEG-3350,NaCl,NaHCO₃,KCl for oral sol.	19-797	S-011	Braintree Labs	7-Oct-1999
CHIBROXIN	Norfloxacin Opthalmic Solution	19-757	S-009	Merck	8-Oct-1999
CORDARONE	Amiodarone HCl Tablets	18-972	S-020	Wyeth Ayerst Labs	8-Oct-1999
XALATAN	Latanoprost Opthalmic Sol.	20-597	S-012	Pharmacia & Upjohn	8-Oct-1999
CIPRO HC	Ciprofloxacin HCl/Hydrocortisone Otic Sol.	20-805	S-003	Alcon	14-Oct-1999
PRAVACHOL	Pravastatin Sodium Tablets	19-898	S-034	Bristol Myers Squibb	14-Oct-1999
SANSERT	Methysergide Maleate Tablets	12-516	S-046	Novartis Pharms	15-Oct-1999
ULTIVA	Remifentanil HCl	20-630	S-001	Glaxo Wellcome	15-Oct-1999
PLEGISOL	Cardioplegic Solution	18-608	S-034	Abbott Labs	18-Oct-1999
EDECRIN	Ethacrynic Acid Tablets	16-092	S-037	Merck	19-Oct-1999
EDECRIN	Ethacrynate Sodium Injection	16-093	S-038	Merck	19-Oct-1999
ZAGAM	Sparfloxacin Tablets	20-677	S-002	Mylan Pharms	19-Oct-1999
BLENOXANE	Bleomycin Sulfate Injection	50-443	S-029	Bristol Myers Squibb	20-Oct-1999
NORVIR	Ritonavir Oral Sol.	20-659	S-021	Abbott Labs	21-Oct-1999
ZANTAC INJECTION	Ranitidine Injection	19-090	S-040	Glaxo Wellcome	22-Oct-1999
ZANTAC PREMIX IV	Ranitidine /Sodium Chloride Injection	19-593	S-030	Glaxo Wellcome	22-Oct-1999
ZANTAC SYRUP	Ranitidine Syrup	19-675	S-022	Glaxo Wellcome	22-Oct-1999
ZANTAC EFFERDOSE	Ranitidine Effervescent Tablets	20-251	S-008	Glaxo Wellcome	22-Oct-1999
ZANTAC TABLETS	Ranitidine Tablets	18-703	S-058	Glaxo Wellcome	22-Oct-1999
ZANTAC GELDOSE	Ranitidine Capsules	20-095	S-010	Glaxo Wellcome	22-Oct-1999
ESTROSTEP	Norethindrone Acetate/Ethinyl Estradiol tablets	20-130	S-005	Parke Davis	25-Oct-1999
TAXOL	Paclitaxel Injection	20-262	S-033	Bristol Myers Squibb	25-Oct-1999
VIRAMUNE	Nevirapine Tablets	20-636	S-011	Boehringer Pharms	25-Oct-1999
VIRAMUNE	Nevirapine Suspension	20-933	S-001	Boehringer Pharms	25-Oct-1999
GLYNASE	Glyburide Tablets	20-051	S-009	Pharmacia & Upjohn	28-Oct-1999
MICRONASE	Glyburide Tablets	17-498	S-021	Pharmacia & Upjohn	28-Oct-1999
NIASPAN	Niacin Extended-Release Tablets	20-381	S-006	KOS Pharms	28-Oct-1999
TOLINASE	Tolazamide Tablets	15-500	S-050	Pharmacia & Upjohn	28-Oct-1999
METHOTREXATE	Methotrexate injection	11-719	S-099	Lederle	29-Oct-1999
METHOTREXATE	Methotrexate tablets	08-085	S-048	Lederle	29-Oct-1999

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Last update: July 7, 2005

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