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Last Updated: December 1, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206098


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NDA 206098 describes ASENAPINE MALEATE, which is a drug marketed by Alembic Pharms Ltd, Breckenridge, and Sigmapharm Labs Llc, and is included in three NDAs. It is available from six suppliers. Additional details are available on the ASENAPINE MALEATE profile page.

The generic ingredient in ASENAPINE MALEATE is asenapine maleate. There are twelve drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
Summary for 206098
Tradename:ASENAPINE MALEATE
Applicant:Alembic Pharms Ltd
Ingredient:asenapine maleate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206098
Suppliers and Packaging for NDA: 206098
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098 ANDA Alembic Pharmaceuticals Limited 46708-198 46708-198-31 100 BLISTER PACK in 1 CARTON (46708-198-31) > 10 TABLET in 1 BLISTER PACK
ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098 ANDA Alembic Pharmaceuticals Limited 46708-198 46708-198-60 60 BLISTER PACK in 1 CARTON (46708-198-60) > 10 TABLET in 1 BLISTER PACK (46708-198-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 5MG BASE
Approval Date:Dec 10, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 10MG BASE
Approval Date:Dec 10, 2020TE:ABRLD:No
Regulatory Exclusivity Expiration:Jun 8, 2021
Regulatory Exclusivity Use:PATENT CHALLENGE

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2.5MG BASE
Approval Date:Jul 19, 2021TE:ABRLD:No

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