Application Information

This drug has been submitted to the FDA under the reference 201578/001.

Names and composition

"SIROLIMUS" is the commercial name of a drug composed of SIROLIMUS.
It belongs to the class Immunosuppressants and is used in Organ transplantation (Infections and Infestations)

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
201578/001 SIROLIMUS SIROLIMUS TABLET/ORAL 1MG
201578/002 SIROLIMUS SIROLIMUS TABLET/ORAL 2MG
201676/001 SIROLIMUS SIROLIMUS TABLET/ ORAL 0.5MG
201676/002 SIROLIMUS SIROLIMUS TABLET/ ORAL 1MG
201676/003 SIROLIMUS SIROLIMUS TABLET/ORAL 0.5MG

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
021083/001 RAPAMUNE SIROLIMUS SOLUTION/ORAL 1MG per ML
021110/001 RAPAMUNE SIROLIMUS TABLET/ORAL 1MG
021110/002 RAPAMUNE SIROLIMUS TABLET/ORAL 2MG
021110/003 RAPAMUNE SIROLIMUS TABLET/ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021110/004 RAPAMUNE SIROLIMUS TABLET/ORAL 0.5MG
201578/001 SIROLIMUS SIROLIMUS TABLET/ORAL 1MG
201578/002 SIROLIMUS SIROLIMUS TABLET/ORAL 2MG
201676/001 SIROLIMUS SIROLIMUS TABLET/ ORAL 0.5MG
201676/002 SIROLIMUS SIROLIMUS TABLET/ ORAL 1MG
201676/003 SIROLIMUS SIROLIMUS TABLET/ORAL 0.5MG

Manufacturers

Manufacturer name
Pfizer Ltd

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