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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021208

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NDA 021208 describes REMERON SOLTAB, which is a drug marketed by Organon Usa Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the REMERON SOLTAB profile page.

The generic ingredient in REMERON SOLTAB is mirtazapine. There are eighteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the mirtazapine profile page.
Summary for 021208
Tradename:REMERON SOLTAB
Applicant:Organon Usa Inc
Ingredient:mirtazapine
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021208
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208 NDA Organon USA Inc. 0052-0106 N 0052-0106-30
REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208 NDA Organon USA Inc. 0052-0108 N 0052-0108-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Jan 12, 2001TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength30MG
Approval Date:Jan 12, 2001TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength45MG
Approval Date:Jan 12, 2001TE:ABRLD:Yes

Expired US Patents for NDA 021208

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-002 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-001 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Organon Usa Inc REMERON SOLTAB mirtazapine TABLET, ORALLY DISINTEGRATING;ORAL 021208-003 Jan 12, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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