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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021292
Company: EMD SERONO INC

Products on NDA 021292

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EUTHYROX	LEVOTHYROXINE SODIUM	0.025MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.05MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.075MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.088MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.1MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.112MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.125MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.137MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.15MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.175MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.2MG	TABLET;ORAL	Discontinued	None	No	No
EUTHYROX	LEVOTHYROXINE SODIUM	0.3MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021292

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2002	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21292ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-292_Novothyrox.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021292Orig1s010ltr.pdf
09/14/2018	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf
09/14/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf
09/14/2018	SUPPL-4	Efficacy-Accelerated Approval Confirmatory Study	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021292Orig1s004,021292Orig1s005,021292Orig1s006ltr.pdf
03/26/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021292s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021292s002ltr.pdf

Labels for NDA 021292

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2022	SUPPL-10	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf
04/27/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021292Orig1s010lbl.pdf
09/14/2018	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
09/14/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
09/14/2018	SUPPL-4	Efficacy-Accelerated Approval Confirmatory Study	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021292s004,021292s005,021292s006lbl.pdf
03/26/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021292s002lbl.pdf
05/31/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21292lbl.pdf

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