Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 212411
Company: SINOTHERAPEUTICS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription AB 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
08/21/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212411Orig1s000ltr.pdf

POSACONAZOLE

TABLET, DELAYED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
NOXAFIL POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 205053 MERCK SHARP DOHME
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 212411 SINOTHERAPEUTICS INC

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