Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208749
Company: MAIA PHARMS INC
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 200MCG/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
12/21/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

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; 200MCG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER;INTRAVENOUS Prescription Yes AP 202231 FRESENIUS KABI USA
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 208749 MAIA PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 200MCG/VIAL POWDER;INTRAVENOUS Prescription No AP 205366 PAR STERILE PRODUCTS

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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