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Cantor Fitzgerald
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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201676

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NDA 201676 describes SIROLIMUS, which is a drug marketed by Dr Reddys Labs Ltd and Zydus Pharms Usa Inc and is included in two NDAs. It is available from four suppliers. Additional details are available on the SIROLIMUS profile page.

The generic ingredient in SIROLIMUS is sirolimus. There are twenty drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 201676
Tradename:SIROLIMUS
Applicant:Zydus Pharms Usa Inc
Ingredient:sirolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201676
Suppliers and Packaging for NDA: 201676
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIROLIMUS sirolimus TABLET;ORAL 201676 ANDA Cadila Healthcare Limited 65841-771 N 65841-771-01
SIROLIMUS sirolimus TABLET;ORAL 201676 ANDA American Health Packaging 68084-956 N 68084-956-25

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jan 8, 2014TE:ABRLD:No

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