Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206043
Company: NOVAST LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE EQ 15MG BASE 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
06/23/2016 ORIG-1 Approval STANDARD

Label is not available on this site.

PRIMAQUINE PHOSPHATE

TABLET;ORAL; EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PRIMAQUINE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription Yes AB 008316 SANOFI AVENTIS US
PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription No AB 203924 ALVOGEN INC
PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription No AB 204476 BAYSHORE PHARMS LLC
PRIMAQUINE PHOSPHATE PRIMAQUINE PHOSPHATE EQ 15MG BASE TABLET;ORAL Prescription No AB 206043 NOVAST LABS

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