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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208691


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NDA 208691 describes SIROLIMUS, which is a drug marketed by Amneal, Apotex, MSN, Novitium Pharma, Torrent, Alkem Labs Ltd, Dr Reddys, Glenmark Pharms Ltd, and Zydus Pharms, and is included in nine 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 208691
Tradename:SIROLIMUS
Applicant:Glenmark Pharms Ltd
Ingredient:sirolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208691
Suppliers and Packaging for NDA: 208691
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIROLIMUS sirolimus TABLET;ORAL 208691 ANDA NORTHSTAR RX LLC 16714-187 16714-187-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-187-01)
SIROLIMUS sirolimus TABLET;ORAL 208691 ANDA NORTHSTAR RX LLC 16714-188 16714-188-01 100 TABLET, FILM COATED in 1 BOTTLE (16714-188-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 16, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 16, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 16, 2020TE:ABRLD:No

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