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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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2022 SUPPL-6 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

07/28/2022 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/28/2022 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 213454 AET PHARMA
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216626 AMNEAL
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 217119 AUROBINDO PHARMA
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 214476 BIOCON PHARMA
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 212500 DR REDDYS
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 214321 HETERO LABS LTD III
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216488 I 3 PHARMS
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 212411 SINOTHERAPEUTICS INC
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 212226 SPECGX LLC
POSACONAZOLE POSACONAZOLE 100MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 216326 WESTMINSTER PHARMS
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