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Generated: September 22, 2017

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Details for New Drug Application (NDA): 077131

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NDA 077131 describes RIVASTIGMINE TARTRATE, which is a drug marketed by Watson Labs, Dr Reddys Labs Inc, Sun Pharm Inds Ltd, Cadila Pharms Ltd, Macleods Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Orchid Hlthcare, and Alembic Pharms Ltd, and is included in nine NDAs. It is available from sixteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.

Summary for NDA: 077131

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077131

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 077131

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL 077131 ANDA Physicians Total Care, Inc. 54868-6145 54868-6145-0 60 CAPSULE in 1 BOTTLE (54868-6145-0)
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL 077131 ANDA Sun Pharmaceutical Industries Limited 62756-145 62756-145-13 500 CAPSULE in 1 BOTTLE (62756-145-13)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Oct 22, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:Oct 22, 2007TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:Oct 22, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Healthtrust
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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