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FDA Drug information

Sirolimus

Read time: 1 mins
Marketing start date: 24 Mar 2025
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Summary of product characteristics


Effective Time

20230927

Version

11

Spl Product Data Elements

sirolimus sirolimus SIROLIMUS SIROLIMUS ALPHA-TOCOPHEROL ACETATE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSPOVIDONE (15 MPA.S AT 5%) FD&C YELLOW NO. 5 FERRIC OXIDE YELLOW GLYCERYL OLEATE HYPROMELLOSES LACTOSE MONOHYDRATE POLOXAMER 188 POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE SUCROSE TALC TITANIUM DIOXIDE YELLOW ROUND 1 sirolimus sirolimus SIROLIMUS SIROLIMUS ALPHA-TOCOPHEROL ACETATE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSPOVIDONE (120 .MU.M) GLYCERYL OLEATE HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE POLOXAMER 188 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 6000 POVIDONE K30 SUCROSE TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 11 sirolimus sirolimus SIROLIMUS SIROLIMUS ALPHA-TOCOPHEROL ACETATE CELLULOSE, MICROCRYSTALLINE CITRIC ACID MONOHYDRATE CROSPOVIDONE (120 .MU.M) FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL OLEATE HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE POLOXAMER 188 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 8000 POVIDONE K30 SUCROSE TALC TITANIUM DIOXIDE YELLOW ROUND 21

Application Number

ANDA201676

Brand Name

Sirolimus

Generic Name

sirolimus

Product Ndc

65841-772

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Sirolimus Tablets, 0.5 mg NDC 65841-771-01 100 Tablets Rx only Sirolimus Tablets, 1 mg NDC 65841-772-01 100 Tablets Rx only Sirolimus Tablets, 2 mg NDC 65841-773-01 100 Tablets Rx only Sirolimus Tablets, 0.5 mg 1 mg label 2 mg label

Drug section

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