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Details for New Drug Application (NDA): 201578

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NDA 201578 describes SIROLIMUS, which is a drug marketed by Zydus Pharms Usa Inc and Dr Reddys Labs Ltd and is included in two NDAs. It is available from four suppliers. Additional details are available on the SIROLIMUS profile page.

The generic ingredient in SIROLIMUS is sirolimus. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the sirolimus profile page.

Summary for NDA: 201578

Tradename:
SIROLIMUS
Applicant:
Dr Reddys Labs Ltd
Ingredient:
sirolimus
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 201578

Mechanism of ActionmTOR Inhibitors
Physiological EffectDecreased Immunologic Activity

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 Dr. Reddy's Laboratories Limited 55111-653 55111-653-01 100 TABLET in 1 BOTTLE (55111-653-01)
SIROLIMUS
sirolimus
TABLET;ORAL 201578 ANDA Dr. Reddy's Laboratories Limited 55111-653 55111-653-30 30 TABLET in 1 BOTTLE (55111-653-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 27, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Oct 27, 2014TE:ABRLD:No


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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 verifification 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.

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