Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076923
Company: X GEN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.01MG BASE/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
08/17/2005 ORIG-1 Approval

Label is not available on this site.

LIOTHYRONINE SODIUM

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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