Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016807
Company: ALLERGAN
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
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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English