U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Original NDA and Original BLA Approvals
October 1998

This report includes NDAs [including NDAs for new molecular entities (NMEs)] and BLAs (including new biological products) approved for the first time during the selected month. Original BLA/NDA approvals by CBER are not included in Drugs@FDA. This report does not include approved NDA or BLA supplements, approved ANDAs, or tentatively approved ANDAs/NDAs.

Click on the Drug Name and Application Number to see information about the drug (for example, regulatory history, labeling, reviews by FDA staff).

This report was produced on September 18, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
10/01/1998 CELLCEPT
NDA #050759
MYCOPHENOLATE MOFETIL Type 3 - New Dosage Form Standard ROCHE PALO
10/09/1998 NEURONTIN
NDA #020882
GABAPENTIN Type 3 - New Dosage Form Standard VIATRIS
10/09/1998 PAXIL
NDA #020885
PAROXETINE HYDROCHLORIDE Type 3 - New Dosage Form Standard APOTEX
10/15/1998 VERSED
NDA #020942
MIDAZOLAM HYDROCHLORIDE Type 3 - New Dosage Form Priority ROCHE
10/21/1998 TIMOLOL MALEATE
NDA #020963
TIMOLOL MALEATE Type 3 - New Dosage Form Standard SANDOZ
10/26/1998 TOPAMAX
NDA #020844
TOPIRAMATE Type 3 - New Dosage Form Standard JANSSEN PHARMS
10/26/1998 TOPAMAX SPRINKLE
NDA #020844
TOPIRAMATE Type 3 - New Dosage Form Standard JANSSEN PHARMS
10/26/1998 ROXICODONE
NDA #020932
OXYCODONE HYDROCHLORIDE Type 3 - New Dosage Form Standard ROXANE
10/29/1998 SONORX
NDA #020773
SIMETHICONE-CELLULOSE Type 3 - New Dosage Form Standard BRACCO
10/30/1998 RENAGEL
NDA #020926
SEVELAMER HYDROCHLORIDE Type 1 - New Molecular Entity Standard GENZYME
Back to Top