Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040089
Company: WEST-WARD PHARMS INT

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
02/28/1995 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2000 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
08/06/1998 SUPPL-1 Manufacturing (CMC)

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 205358 PAR STERILE PRODUCTS
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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