Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203729
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;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
07/15/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2019 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

QUININE SULFATE

CAPSULE;ORAL; 324MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
QUALAQUIN QUININE SULFATE 324MG CAPSULE;ORAL Prescription Yes AB 021799 SUN PHARM INDUSTRIES
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 203729 AMNEAL PHARMS
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 203112 LUPIN LTD
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 204372 NOVAST LABS
QUININE SULFATE QUININE SULFATE 324MG CAPSULE;ORAL Prescription No AB 091661 TEVA PHARMS

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