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Reference Listed Drug Labeling Approved in June 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
HIVID Zalcitabine tablets 20-199 S-013 Roche 01-Jun-1999
PROVENTIL-HFA Albuterol sulfate inhalation aerosol 20-503 S-011 3M Pharmaceuticals 02-Jun-1999
CRIXIVAN Indivir sulfate capsules 20-685 S-023 et al Merck Research 04-Jun-1999
VERALAN PM Verapamil HCl extended-release capsules 20-493 S-002 Elan Pharmaceutical 04-Jun-1999
DOPAMINE Dopamine HCl in 5% dextrose injection 18-826 S-026 Abbott laboratories 05-Jun-1999
VERELAN Verapamil HCl extended-release capsules 19-614 S-027 Elan Pharmaceutical 05-Jun-1999
TRUSOPT Dorzolamide HCl opthalmic solution 20-408 S-016 Merck 06-Jun-1999
PREVEN Levonorgestrel/ethinyl estradiol tablets 20-946 S-001 Gynetics 07-Jun-1999
PREMARIN Conjugated estrogen tablets 04-782 S-109 Wyeth Ayerst 08-Jun-1999
QUINIDINE GLUCONATE Quinidine gluconate injection 07-529 S-017 Lilly 09-Jun-1999
DIOVAN HCT Valsartan/hydrochlorothiazide tablets 20-818 S-004 Novartis 16-Jun-1999
FOSAMAX Alendronate sodium tablets 20-560 S-012 Merck 16-Jun-1999
ISORDIL SL Isosorbide dinitrate sublingual tablets 12-940 S-043 Wyeth 16-Jun-1999
ISORDIL ORAL Isosorbide dinitrate sublingual tablets 12-093 S-043 Wyeth 16-Jun-1999
LOTREL Amlodipine besylate/benazepril HCl capsules 20-364 S-008 Novartis 16-Jun-1999
PROZAC Fluoxetine HCl capsules 18-936 S-059 Lilly Research 16-Jun-1999
PROZAC Fluoxetine HCl oral solution 20-101 S-026 Lilly Research 16-Jun-1999
CUTIVATE Fluticasone proprionate cream 19-958 S-008,011 Glaxo Wellcome 17-Jun-1999
VIAGRA Sildenafil citrate tablets 20-895 S-006 Pfizer 18-Jun-1999
NORPLANT Levonorgestrel implant 20-088 S-012 Wyeth Ayerst 21-Jun-1999
ULTIVA Remifentanil HCl for injection 20-630 S-003 Glaxo Wellcome 23-Jun-1999
ETHYOL Amifostine for injection 20-221 S-012 US Bioscience 24-Jun-1999
MIVACRON Mivacurium Cl 20-098 S-010 Glaxo Wellcome 25-Jun-1999
DOXIL Doxorubicin HCl liposome injection 50-718 S-006 ALZA 28-Jun-1999
HELIDAC Olsalazine capsules 19-715 S-017 Pharmacia & Upjohn 30-Jun-1999

 

PDF requires the free Adobe Acrobat Reader

Date created: August 11, 1999; last update: July 7, 2005

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