Drugs@FDA: FDA-Approved Drugs
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. |
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12/13/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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. |
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05/17/1999 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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05/16/1996 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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04/16/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
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03/06/1989 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/17/1987 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/08/1985 | SUPPL-18 | Labeling |
Label is not available on this site. |
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12/14/1982 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/15/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/12/1980 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/08/1980 | SUPPL-12 | Labeling |
Label is not available on this site. |
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04/12/1979 | SUPPL-11 | Labeling |
Label is not available on this site. |
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06/26/1975 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/26/1975 | SUPPL-3 | Labeling |
Label is not available on this site. |
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06/26/1975 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/26/1975 | SUPPL-1 | Labeling |
Label is not available on this site. |