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FDA Approval

sirolimus

CompanyNovadoz Pharmaceuticals LLC (DUNS: 081109687)

Effective Date

February 14, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Sirolimus(1 mg in 1 mL)

Manufacturing Establishments (1)

MSN Pharmaceuticals Inc.

Labeler

Novadoz Pharmaceuticals LLC

DUNS Number

079229051

Products (1)

sirolimus

NDC Product Code

72205-099

Application Number

ANDA216728

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

February 14, 2023

Ingredients

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SirolimusActive

Code: W36ZG6FT64Class: ACTIBQuantity: 1 mg in 1 mL

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

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