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Details for New Drug Application (NDA): 077129

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NDA 077129 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: 077129

Watson Labs
rivastigmine tartrate
Therapeutic Class:Antidementia Agents

Pharmacology for NDA: 077129

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 077129

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
rivastigmine tartrate
CAPSULE;ORAL 077129 ANDA Watson Laboratories, Inc. 0591-3208 0591-3208-44 100 CAPSULE in 1 DOSE PACK (0591-3208-44)
rivastigmine tartrate
CAPSULE;ORAL 077129 ANDA Watson Laboratories, Inc. 0591-3208 0591-3208-60 60 CAPSULE in 1 BOTTLE (0591-3208-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Jan 8, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:Jan 8, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:Jan 8, 2008TE:ABRLD:No

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