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Details for New Drug Application (NDA): 090879

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NDA 090879 describes RIVASTIGMINE TARTRATE, which is a drug marketed by Watson Labs, Dr Reddys Labs Inc, Sun Pharm Inds, Macleods Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Orchid Hlthcare, and Alembic Pharms Ltd, and is included in eight NDAs. It is available from fourteen suppliers. Additional details are available on the RIVASTIGMINE TARTRATE profile page.

The generic ingredient in RIVASTIGMINE TARTRATE is rivastigmine tartrate. There are thirty-two drug master file entries for this compound. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the rivastigmine tartrate profile page.

Summary for NDA: 090879

Tradename:
RIVASTIGMINE TARTRATE
Applicant:
Orchid Hlthcare
Ingredient:
rivastigmine tartrate
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Jun 10, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:Jun 10, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:Jun 10, 2015TE:ABRLD:No


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