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Profile for Applicant: Janssen Pharma

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Summary for Applicant: Janssen Pharma

Patents:1
Tradenames:4
Ingredients:4
NDAs:5
Drug Master File Entries: (click here to view)93
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharma
ERGAMISOL
levamisole hydrochloride
TABLET;ORAL020035Jun 18, 1990DISCNNo<disabled><disabled>
Janssen Pharma
PROPULSID QUICKSOLV
cisapride monohydrate
TABLET, ORALLY DISINTEGRATING;ORAL020767Nov 7, 1997DISCNNo5,648,093<disabled><disabled>
Janssen Pharma
MONISTAT
miconazole
INJECTABLE;INJECTION018040Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Janssen Pharma
NIZORAL
ketoconazole
CREAM;TOPICAL019084Dec 31, 1985DISCNNo<disabled><disabled>
Janssen Pharma
NIZORAL
ketoconazole
SUSPENSION;ORAL070767Nov 7, 1986DISCNNo<disabled><disabled>
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