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Reference Listed Drug Labeling Approved in August 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 PDF Doc format.

Product Established Name NDA/Supp #
August 1 RENOVA tretinoin cream 19-963/S-007
August 3 CUPRIC CHLORIDE cupric chloride injection 18-960/S-010
FRAGMIN dalteparin Na injection 20-287/S-018
August 9 LUVOX fluvoxamine maleate tablets 20-243/S-022
August 10 VIRAMUNE nevirapine tablets 20-636/S-013
VIRAMUNE nevirapine oral suspension 20-933/S-002
August 11 LOTRONEX alsetron HCl tablets 21-107/S-002
NORDITROPIN somatropin (rDNA origin) for injection 19-721/S-007
August 14 ASACOL mesalamine tablets 19-651/S- 011
August 16 VIVELLE estradiol transdermal system 20-323/S-023
August 18 GENOTROPIN somatropin (rDNA origin) for injection 20-280/S-028
August 22 MEVACOR lovastatin tablets 19-643/S-059
ZOCOR simvastatin tablets 19-766/S-039
August 23 ALEVE naproxen tablets 20-204/S-010
AVENTYL nortriptyline HCl capsules 14-684/S-040
AVENTYL nortriptyline HCl oral solution 14-685/S-024
ORUDIS-KT ketoprofen tablets 20-429/S-004
August 24 COSOPT dorzolamide HCl/timolol maleate ophth sol 20-869/S-006
NORCURON vecuronium Br for injection 18-776/S-023
VELBAN vinblastine sulfate injection 12-665/S-039
August 25 NAVELBINE vinorelbine tartrate injection 20-388/S-011
MOTRIN IB ibuprofen tablets 19-012/S-017
RAPAMUNE sirolimus oral solution 21-083/S-004
ROCEPHIN ceftriaxone sodium for injection 50-585/S-047
XALATAN latanoprost ophthalmic solution 20-597/S-018
August 28 NUTROPIN somatropin (rDNA origin) for injection 20-168/S-016
PLENDIL felodipine tablets 19-834/S-015
PRIMAXIN imipenem/cilastatin for injection 50-587/S-052
August 29 ANATABUSE disuliram tablets 07-883/S-030
REMERON mirtazapine tablets 20-415/S-006
CIPRO ciprofloxacin tablets 19-537/S-038
CIPRO ciprofloxacin injection 19-847/S-024
CIPRO ciprofloxacin  oral suspension 20-780/S-008
CIPRO ciprofloxacin and dextrose injection 19-857/S-027
August 30 VISTARIL hydroxyzine pamoate capsules 11-459/S-035
 

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Last Updated: January 18, 2006
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