Details for New Drug Application (NDA): 211040
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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 211040
Tradename: | SIROLIMUS |
Applicant: | Novitium Pharma |
Ingredient: | sirolimus |
Patents: | 0 |
Pharmacology for NDA: 211040
Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 211040
Suppliers and Packaging for NDA: 211040
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIROLIMUS | sirolimus | SOLUTION;ORAL | 211040 | ANDA | VistaPharm, LLC | 66689-347 | 66689-347-02 | 1 CARTON in 1 KIT (66689-347-02) / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Jan 28, 2019 | TE: | AA | RLD: | No |
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