You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

Details for New Drug Application (NDA): 214753


✉ Email this page to a colleague

« Back to Dashboard


NDA 214753 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 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.