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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078639
Company: MYLAN INSTITUTIONAL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription AP No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/03/2008 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
12/23/2020 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

FOMEPIZOLE

INJECTABLE;INJECTION; 1.5GM/1.5ML (1GM/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription No AP 078368 AM REGENT
FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription No AP 216791 GLAND
FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription No AP 078639 MYLAN INSTITUTIONAL
FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription No AP 078537 NAVINTA LLC
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