Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 211510
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET;ORAL Prescription AB No No
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET;ORAL Prescription AB No No
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET;ORAL Prescription AB 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
10/26/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

LIOTHYRONINE SODIUM

TABLET;ORAL; EQ 0.005MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOMEL LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET;ORAL Prescription Yes AB 010379 KING PHARMS
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET;ORAL Prescription No AB 090097 MAYNE PHARMA INC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET;ORAL Prescription No AB 200295 SIGMAPHARM LABS LLC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET;ORAL Prescription No AB 091382 SUN PHARM
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.005MG BASE TABLET;ORAL Prescription No AB 211510 TEVA PHARMS USA

TABLET;ORAL; EQ 0.025MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOMEL LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET;ORAL Prescription Yes AB 010379 KING PHARMS
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET;ORAL Prescription No AB 090097 MAYNE PHARMA INC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET;ORAL Prescription No AB 200295 SIGMAPHARM LABS LLC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET;ORAL Prescription No AB 091382 SUN PHARM
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.025MG BASE TABLET;ORAL Prescription No AB 211510 TEVA PHARMS USA

TABLET;ORAL; EQ 0.05MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CYTOMEL LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET;ORAL Prescription Yes AB 010379 KING PHARMS
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET;ORAL Prescription No AB 090097 MAYNE PHARMA INC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET;ORAL Prescription No AB 200295 SIGMAPHARM LABS LLC
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET;ORAL Prescription No AB 091382 SUN PHARM
LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM EQ 0.05MG BASE TABLET;ORAL Prescription No AB 211510 TEVA PHARMS USA

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