Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204732
Company: MYLAN LABS LTD
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
01/26/2017 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204732Orig1s000ltr.pdf

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 AUROBINDO PHARMA LTD
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 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 204732 MYLAN LABS LTD
AZITHROMYCIN AZITHROMYCIN EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065506 SAGENT STRIDES
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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