Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211040
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SIROLIMUS SIROLIMUS 1MG/ML SOLUTION;ORAL Prescription AA No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/28/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211040Orig1s000ltr.pdf

SIROLIMUS

SOLUTION;ORAL; 1MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RAPAMUNE SIROLIMUS 1MG/ML SOLUTION;ORAL Prescription Yes AA 021083 PF PRISM CV
SIROLIMUS SIROLIMUS 1MG/ML SOLUTION;ORAL Prescription No AA 211040 NOVITIUM PHARMA

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