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Reference Listed Drug Labeling Approved in September 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 #
Sept 1 ARMIDEX anastrozole tablets 20-541/S-006
       
Sept 6 MYLERAN busulfan tablets 09-386/S-018
  HEPARIN heparin sodium injection 17-007/S-038
  SERENTIL mesoridazine besylate tablet 16-774/S-072
  SERENTIL mesoridazine besylate oral solution 16-775/S-040
  SERENTIL mesoridazine besylate injection 16-997/S-040
       
Sept 7 EXCEDRIN MIGRAINE acetaminophen/aspirin/caffeine tablets 20-802/S-004
  PEDIATRIC ADVIL DROPS ibuprofen oral suspension 20-812/S-007
       
Sept 8 DIPENTUM olsalazine capsules 19-715/S-019
  LAMICTAL lamotrigine tablets 20-241/S-014
  LEVAQUIN levofloxacin tablets 20-634/S-013
  LEVAQUIN levofloxacin injection 20-635/S-010
       
Sept 13 PRIFTIN rifapentine tablets 21-024/S-004
  ZEMPLAR paricacitol injection 20-819/S-004
       
Sept 15 ASTELIN azelastin HCl nasal solution 20-114/S-006
       
Sept 18 TIMOPTIC timolol maleate opthalmic solution 18-086/S-053
  TIMOPTIC-XE timolol maleate opthalmic solution 20-330/S-014
  TRUSOPT dorzolamide HCl opthalmic solution 20-408/S-021
       
Sept 20 AVAPRO irbesartan tablets 20-757/S-017
  AVALIDE irbesartan/hydrochloroathiazie tablets 20-758/S-018
  MAXIPIME cefepime HCl for injection 50-679/S-013
  TRANSDERM-NITRO nitroglycerin transdermal system 20-144/S-019
       
Sept 21 FLOLAN epoprostenol sodium for injection 20-444/S-005
       
Sept 22 ERYC erythromycin delayed-release capsules 50-536/S-013
  MARINOL dronabinol capsules 18-651/S-013
       
Sept 26 ATIVAN lorazepam injection 18-140/S-026
  AZULFIDINE sulfasalazine tablets 07-073/S-118
  SULAR nisoldipine extended-release tablets 20-356/S-011
       
Sept 27 ZERIT stavudine capsules 20-412/S-013
  ZERIT stavudine oral solution 20-413/S-005
       
Sept 28 LUVOX fluvoxamine maleate tablets 20-243/S-021
  PAXIL paroxetine HCl tablets 20-031/S-030
  PAXIL paroxetine HCl oral suspension 20-710/S-008
Sept 29 COMBIVIR lamivudine/zidovudine tablets 20-857/S-008
  FOSAMAX alendronate sodium tablets 20-560/S-023
       
 

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