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Drugs@FDA: FDA-Approved Drugs

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Original NDA and Original BLA Approvals
June 1996

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 October 06, 2024.

Approval Date Drug Name Active Ingredients Submission Classification * Review Priority ** Company
06/05/1996 XALATAN
NDA #020597		 LATANOPROST Type 1 - New Molecular Entity Priority UPJOHN
06/10/1996 RISPERDAL
NDA #020588		 RISPERIDONE Type 3 - New Dosage Form Standard JANSSEN PHARMS
06/10/1996 JUNIOR STRENGTH MOTRIN
NDA #020602		 IBUPROFEN Type 8 - Partial Rx to OTC Switch Standard J AND J CONSUMER INC
06/10/1996 CHILDREN'S MOTRIN
NDA #020603		 IBUPROFEN Type 3 - New Dosage Form Standard J AND J CONSUMER INC
06/11/1996 ALBENZA
NDA #020666		 ALBENDAZOLE Type 1 - New Molecular Entity Priority IMPAX LABS INC
06/12/1996 ZITHROMAX
NDA #050730		 AZITHROMYCIN Type 3 - New Dosage Form Priority PFIZER
06/14/1996 REMERON
NDA #020415		 MIRTAZAPINE Type 1 - New Molecular Entity Standard ORGANON
06/14/1996 HUMALOG
BLA #020563		 INSULIN LISPRO RECOMBINANT LILLY
06/14/1996 HUMALOG KWIKPEN
BLA #020563		 INSULIN LISPRO RECOMBINANT LILLY
06/14/1996 HUMALOG PEN
BLA #020563		 INSULIN LISPRO RECOMBINANT LILLY
06/14/1996 HUMALOG TEMPO PEN
BLA #020563		 INSULIN LISPRO RECOMBINANT LILLY
06/14/1996 CAMPTOSAR
NDA #020571		 IRINOTECAN HYDROCHLORIDE Type 1 - New Molecular Entity Priority PFIZER INC
06/21/1996 VIRAMUNE
NDA #020636		 NEVIRAPINE Type 1 - New Molecular Entity Priority BOEHRINGER INGELHEIM
06/21/1996 MERREM
NDA #050706		 MEROPENEM Type 1 - New Molecular Entity Standard PFIZER
06/26/1996 VANCENASE AQ
NDA #020469		 BECLOMETHASONE DIPROPIONATE MONOHYDRATE Type 3 - New Dosage Form Standard SCHERING
06/26/1996 VISTIDE
NDA #020638		 CIDOFOVIR Type 1 - New Molecular Entity Standard GILEAD SCIENCES INC
06/27/1996 CHILDREN'S ADVIL
NDA #020589		 IBUPROFEN Type 8 - Partial Rx to OTC Switch Standard HALEON US HOLDINGS
06/27/1996 CHILDREN'S ADVIL-FLAVORED
NDA #020589		 IBUPROFEN Type 8 - Partial Rx to OTC Switch Standard HALEON US HOLDINGS
06/28/1996 CECLOR CD
NDA #050673		 CEFACLOR Type 3 - New Dosage Form Standard LILLY
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