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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 214753


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NDA 214753 describes SIROLIMUS, which is a drug marketed by Amneal, Apotex, Hetero Labs Ltd V, MSN, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in ten NDAs. It is available from fourteen 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. Eighteen 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
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 Major Pharmaceuticals 0904-7248 0904-7248-04 30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET in 1 BLISTER PACK
SIROLIMUS sirolimus TABLET;ORAL 214753 ANDA Ascend Laboratories, LLC 67877-746 67877-746-01 100 TABLET in 1 BOTTLE (67877-746-01)

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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