Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206533
Company: ZYDUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM 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
04/15/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETAZOLAMIDE SODIUM

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
ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202693 EMCURE PHARMS LTD
ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200880 MYLAN ASI
ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040089 WEST-WARD PHARMS INT
ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040784 X GEN PHARMS
ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206533 ZYDUS PHARMS

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