Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205358
Company: PAR STERILE PRODUCTS
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
06/20/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205358Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205358rig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/20/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205358Orig1s000lbl.pdf

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 205358 PAR STERILE PRODUCTS
ACETAZOLAMIDE SODIUM ACETAZOLAMIDE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 200880 SAGENT AGILA
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

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