Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211369
Company: TEVA PHARMS USA INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG CAPSULE;ORAL Prescription AB No No
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG CAPSULE;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
10/28/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211369Orig1s000ltr.pdf

LEVOTHYROXINE SODIUM

CAPSULE;ORAL; 0.075MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.075MG CAPSULE;ORAL Prescription No AB 211369 TEVA PHARMS USA INC
TIROSINT LEVOTHYROXINE SODIUM 0.075MG CAPSULE;ORAL Prescription Yes AB 021924 INSTITUT BIOCHIMIQUE

CAPSULE;ORAL; 0.15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM 0.15MG CAPSULE;ORAL Prescription No AB 211369 TEVA PHARMS USA INC
TIROSINT LEVOTHYROXINE SODIUM 0.15MG CAPSULE;ORAL Prescription Yes AB 021924 INSTITUT BIOCHIMIQUE

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