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Abbreviated New Drug Application (ANDA): 215259
Company: ASCENT PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription AB4 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
01/18/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

LEVOTHYROXINE SODIUM

TABLET;ORAL; 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN

TABLET;ORAL; 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TE Code = AB4

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOLET LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 021137 GENUS LIFESCIENCES
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 212399 ACCORD HLTHCARE
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 215259 ASCENT PHARMS INC
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 076187 MYLAN
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription No AB4 207588 WATSON LABS TEVA
THYRO-TABS LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium TABLET;ORAL Prescription Yes AB4 021116 ALVOGEN
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