Drugs@FDA: FDA-Approved Drugs

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 20, 2024.

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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

Original NDA and Original BLA Approvals October 1998

Original NDA and Original BLA Approvals
October 1998