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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065173
Company: HERITAGE PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROMOMYCIN SULFATE PAROMOMYCIN SULFATE EQ 250MG BASE CAPSULE;ORAL Prescription AA,TBD 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
12/14/2007 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
10/28/2015 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

PAROMOMYCIN SULFATE

CAPSULE;ORAL; EQ 250MG BASE
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PAROMOMYCIN SULFATE PAROMOMYCIN SULFATE EQ 250MG BASE CAPSULE;ORAL Prescription No AA 065173 HERITAGE PHARMS
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