Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020105
Company: PAR STERILE PRODUCTS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRIOSTAT LIOTHYRONINE SODIUM EQ 0.01MG BASE/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
12/31/1991 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; 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
05/20/2002 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20105s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20105s002ltr.pdf
06/09/2000 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/20/2002 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20105s2lbl.pdf

TRIOSTAT

INJECTABLE;INJECTION; EQ 0.01MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.01MG BASE/ML INJECTABLE;INJECTION Prescription No AP 076923 X GEN PHARMS
TRIOSTAT LIOTHYRONINE SODIUM EQ 0.01MG BASE/ML INJECTABLE;INJECTION Prescription Yes AP 020105 PAR STERILE PRODUCTS

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