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Reference Listed Drug Labeling Approved in July 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 #
July 3 BACTRIM DS trimethoprim/sulfamethoxazole tablets 17-377/S-050
VIDEX didanosine tablets 20-154/S-031
didanosine for oral solution 20-155/S-022
       
July 6 COPAXONE glatimer acetate for injection 20-622/S-009
PHOTOFRIN porfimer sodium injection 20-451/S-006
       
July 7 ACULAR PF ketorolac tromethamine ophthalmic solution 20-811/S-002
BETAPACE sotalol HCl tablets 19-865/S-011
CILOXAN ciprofloxacin HCl ophthalmic ointment 20-369/S-004
       
July 11 AVANDIA rosiglitazone tablets 21-071/S-002
GENOTROPIN somatropin (rDNA origin) for injection 20-280/S-025
PROCAINBID procainamide HCl tablets 20-545/S-004
       
July 12 NORVASC amlodipine besylate tablets 19-787/S-017
VASCOR bepridil HCl tablets 19-002/S-009
       
July 14 FEMHRT norethindrone acetate/ethinyl estradiol tablets 21-065/S-004
       
July 17 SEROSTIM somatropin (rDNA origin) for injection 20-604/S-009
       
July 18 LEXXEL enalapril maleate/felodipine tablets 20-668/S-006
       
July 24 TRASYLOL aprotinin injection 20-304/S-009
VIDEX didanosine tablets 20-154/S-032
  didanosine for oral solution 20-155/S-023
       
July 25 TYLENOL actaminophen extended-release tablet 19-872/S-010
       
July 26 SERZONE nefazadone HCl tablets 20-152/S-006
THAM tromethamine injection 13-025/S-035
       
July 27 CELLCEPT mycophenolate mofetil HCl for injection 50-758/S-003
  mycophenolate mofetil capsules 50-722/S-004
  mycophenolate mofetil tablets 50-723/S-003
  mycophenolate mofetil for oral suspension 50-759/S-004
ZIAGEN abacavir sulfate oral solution 20-978/S-004
  abacavir sulfate tablets 20-977/S-003
       
 

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Last Updated: October 02, 2001
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