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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice

Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201578

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NDA 201578 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 five 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. Seven suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 201578
Applicant:Dr Reddys Labs Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 201578
Suppliers and Packaging for NDA: 201578
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIROLIMUS sirolimus TABLET;ORAL 201578 ANDA AvPAK 50268-718 N 50268-718-13
SIROLIMUS sirolimus TABLET;ORAL 201578 ANDA Dr. Reddy's Laboratories Limited 55111-653 N 55111-653-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 27, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 27, 2014TE:ABRLD:No

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