Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020696
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANTIZOL FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription AP Yes 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
12/04/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2013 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/08/2000 SUPPL-1 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20696s001ltr.pdf

ANTIZOL

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
ANTIZOL FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription Yes AP 020696 PAR PHARM INC
FOMEPIZOLE FOMEPIZOLE 1.5GM/1.5ML (1GM/ML) INJECTABLE;INJECTION Prescription No AP 078368 LUITPOLD
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English