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Last Updated: June 13, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201578


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NDA 201578 describes SIROLIMUS, which is a drug marketed by Amneal, Apotex, Novitium Pharma, Alkem Labs Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, and Zydus Pharms, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the SIROLIMUS profile page.

The generic ingredient in SIROLIMUS is sirolimus. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 201578
Tradename:SIROLIMUS
Applicant:Dr Reddys Labs Ltd
Ingredient:sirolimus
Patents:0
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 50268-718-13 30 BLISTER PACK in 1 BOX (50268-718-13) > 1 TABLET in 1 BLISTER PACK (50268-718-11)
SIROLIMUS sirolimus TABLET;ORAL 201578 ANDA Dr. Reddy's Laboratories Limited 55111-653 55111-653-01 100 TABLET in 1 BOTTLE (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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