Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017851
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIORESAL BACLOFEN 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LIORESAL BACLOFEN 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
11/22/1977 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2000 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

04/21/1999 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1995 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/1995 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/05/1990 SUPPL-36 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/17/1989 SUPPL-34 Labeling

Label is not available on this site.

04/07/1989 SUPPL-31 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/16/1984 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1984 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/15/1984 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1986 SUPPL-25 Labeling

Label is not available on this site.

03/21/1984 SUPPL-24 Labeling

Label is not available on this site.

03/07/1983 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/1982 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1982 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/02/1983 SUPPL-19 Labeling

Label is not available on this site.

01/24/1985 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/1981 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/20/1982 SUPPL-15 Labeling

Label is not available on this site.

05/14/1981 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/14/1981 SUPPL-13 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/21/1981 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/06/1980 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/23/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/19/1980 SUPPL-8 Labeling

Label is not available on this site.

02/03/1981 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/13/1979 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/31/1979 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/31/1979 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/1979 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/1978 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/04/1978 SUPPL-1 Labeling

Label is not available on this site.

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