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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207127
Company: CEROVENE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PYRIMETHAMINE PYRIMETHAMINE 25MG TABLET;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
02/28/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207127Orig1s000ltr.pdf

PYRIMETHAMINE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DARAPRIM PYRIMETHAMINE 25MG TABLET;ORAL Prescription Yes AB 008578 VYERA PHARMS LLC
PYRIMETHAMINE PYRIMETHAMINE 25MG TABLET;ORAL Prescription No AB 211271 ALVOGEN
PYRIMETHAMINE PYRIMETHAMINE 25MG TABLET;ORAL Prescription No AB 216983 AUROBINDO PHARMA LTD
PYRIMETHAMINE PYRIMETHAMINE 25MG TABLET;ORAL Prescription No AB 207127 CEROVENE INC
PYRIMETHAMINE PYRIMETHAMINE 25MG TABLET;ORAL Prescription No AB 215506 TEVA PHARMS
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