Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016807
Company: ALLERGAN

Products on NDA 016807

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
THYROLAR-0.25	LIOTRIX (T4;T3)	0.0125MG;0.0031MG	TABLET;ORAL	Discontinued	None	Yes	No
THYROLAR-0.5	LIOTRIX (T4;T3)	0.025MG;0.0063MG	TABLET;ORAL	Discontinued	None	Yes	No
THYROLAR-1	LIOTRIX (T4;T3)	0.05MG;0.0125MG	TABLET;ORAL	Discontinued	None	Yes	No
THYROLAR-2	LIOTRIX (T4;T3)	0.1MG;0.025MG	TABLET;ORAL	Discontinued	None	Yes	No
THYROLAR-3	LIOTRIX (T4;T3)	0.15MG;0.0375MG	TABLET;ORAL	Discontinued	None	Yes	No
THYROLAR-5	LIOTRIX (T4;T3)	0.25MG;0.0625MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/1969	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2014	SUPPL-33	Manufacturing (CMC)		Label is not available on this site.
12/13/2002	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
10/01/2002	SUPPL-25	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16807slr025ltr.pdf
06/08/2001	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
05/17/1999	SUPPL-23	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/16/1996	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/16/1990	SUPPL-21	Labeling		Label is not available on this site.
03/06/1989	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
04/17/1987	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/08/1985	SUPPL-18	Labeling		Label is not available on this site.
12/14/1982	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1980	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
08/12/1980	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
01/08/1980	SUPPL-12	Labeling		Label is not available on this site.
04/12/1979	SUPPL-11	Labeling		Label is not available on this site.
06/26/1975	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1975	SUPPL-3	Labeling		Label is not available on this site.
06/26/1975	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
06/26/1975	SUPPL-1	Labeling		Label is not available on this site.