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Abbreviated New Drug Application (ANDA): 208820
Company: ENDO OPERATIONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRAZIQUANTEL PRAZIQUANTEL 600MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/27/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208820Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/22/2024 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/08/2022 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PRAZIQUANTEL

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRAZIQUANTEL PRAZIQUANTEL 600MG TABLET;ORAL Prescription No AB 208820 ENDO OPERATIONS
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