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Abbreviated New Drug Application (ANDA): 203412
Company: HAINAN POLY PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
10/09/2018 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203412Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/19/2020 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

AZITHROMYCIN

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203294 EUGIA PHARMA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065179 FRESENIUS KABI USA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065501 GLAND PHARMA LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 203412 HAINAN POLY PHARM
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065500 HOSPIRA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065511 HOSPIRA
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090923 SUN PHARM INDS LTD
ZITHROMAX AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050733 PFIZER
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