Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211369
Company: ANI PHARMS

Products on ANDA 211369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG	CAPSULE;ORAL	Discontinued	None	No	No
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211369

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/02/2023	SUPPL-5	Labeling-Patient Package Insert, Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.