Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206163
Company: PIRAMAL CRITICAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription AP No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS 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
06/29/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206163ORig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206163Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/29/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206163ORig1s000lbl.pdf

LEVOTHYROXINE SODIUM

POWDER;INTRAVENOUS; 100MCG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 202231 FRESENIUS KABI USA
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 208749 MAIA PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 100MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 206163 PIRAMAL CRITICAL

POWDER;INTRAVENOUS; 500MCG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 202231 FRESENIUS KABI USA
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 208749 MAIA PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 500MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 206163 PIRAMAL CRITICAL

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