Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078368
Company: AM REGENT
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 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
12/14/2007 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078368s000ltr.pdf

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 078639 MYLAN INSTITUTIONAL
FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription No AP 078537 NAVINTA LLC

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