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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207531
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription AB No No
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;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
04/09/2018 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207531Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/14/2022 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

07/25/2019 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

AZITHROMYCIN

FOR SUSPENSION;ORAL; EQ 100MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 205666 AMNEAL
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 209201 AUROBINDO PHARMA LTD
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 207531 EPIC PHARMA LLC
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065246 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 211147 ZYDUS
ZITHROMAX AZITHROMYCIN EQ 100MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050710 PFIZER

FOR SUSPENSION;ORAL; EQ 200MG BASE/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 205666 AMNEAL
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 209201 AUROBINDO PHARMA LTD
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 207531 EPIC PHARMA LLC
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065246 PLIVA
AZITHROMYCIN AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 211147 ZYDUS
ZITHROMAX AZITHROMYCIN EQ 200MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050710 PFIZER
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