Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
November 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 December 01, 2021.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
11/02/1998 ENBREL
BLA #103795
ETANERCEPT IMMUNEX
11/04/1998 ACTIQ
NDA #020747
FENTANYL CITRATE Type 3 - New Dosage Form Standard CEPHALON
11/10/1998 MICARDIS
NDA #020850
TELMISARTAN Type 1 - New Molecular Entity Standard BOEHRINGER INGELHEIM
11/18/1998 ACTIVELLA
NDA #020907
ESTRADIOL; NORETHINDRONE ACETATE Type 4 - New Combination Standard AMNEAL
11/20/1998 ROCALTROL
NDA #021068
CALCITRIOL Type 3 - New Dosage Form Standard VALIDUS PHARMS
11/24/1998 GYNE-LOTRIMIN 3
NDA #020574
CLOTRIMAZOLE Type 3 - New Dosage Form Standard BAYER HEALTHCARE LLC
11/24/1998 METROLOTION
NDA #020901
METRONIDAZOLE Type 3 - New Dosage Form Standard GALDERMA LABS LP
11/25/1998 VERELAN PM
NDA #020943
VERAPAMIL HYDROCHLORIDE Type 3 - New Dosage Form Standard RECRO GAINESVILLE
11/25/1998 SANDOSTATIN LAR
NDA #021008
OCTREOTIDE ACETATE Type 3 - New Dosage Form Priority NOVARTIS
11/30/1998 THYROGEN
BLA #020898
THYROTROPIN ALFA GENZYME

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