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Last Updated: June 12, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 214753


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NDA 214753 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 214753
Tradename:SIROLIMUS
Applicant:Alkem Labs Ltd
Ingredient:sirolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214753
Suppliers and Packaging for NDA: 214753
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIROLIMUS sirolimus TABLET;ORAL 214753 ANDA Ascend Laboratories, LLC 67877-746 67877-746-01 100 TABLET in 1 BOTTLE (67877-746-01)
SIROLIMUS sirolimus TABLET;ORAL 214753 ANDA Ascend Laboratories, LLC 67877-746 67877-746-05 500 TABLET in 1 BOTTLE (67877-746-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Mar 12, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Mar 12, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Mar 12, 2021TE:ABRLD:No

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