Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207383
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMSIROLIMUS TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription AP 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
08/16/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

TEMSIROLIMUS

SOLUTION;INTRAVENOUS; 25MG/ML (25MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TEMSIROLIMUS TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203153 ACCORD HLTHCARE
TEMSIROLIMUS TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 207383 GLAND PHARMA LTD
TORISEL TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION;INTRAVENOUS Prescription Yes AP 022088 PF PRISM CV

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