Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017851
Company: NOVARTIS

Products on NDA 017851

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LIORESAL	BACLOFEN	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
LIORESAL	BACLOFEN	20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017851

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.