Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016912
Company: ROCHE

Products on NDA 016912

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LARODOPA	LEVODOPA	250MG	CAPSULE;ORAL	Discontinued	None	No	No
LARODOPA	LEVODOPA	100MG	CAPSULE;ORAL	Discontinued	None	No	No
LARODOPA	LEVODOPA	250MG	TABLET;ORAL	Discontinued	None	No	No
LARODOPA	LEVODOPA	500MG	TABLET;ORAL	Discontinued	None	No	No
LARODOPA	LEVODOPA	100MG	TABLET;ORAL	Discontinued	None	No	No
LARODOPA	LEVODOPA	500MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016912

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/1970	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
08/19/1998	SUPPL-48	Manufacturing (CMC)-Control		Label is not available on this site.
05/08/1998	SUPPL-47	Manufacturing (CMC)-Control		Label is not available on this site.
09/05/1997	SUPPL-46	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/1997	SUPPL-45	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/30/1997	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
01/08/1993	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
01/03/1986	SUPPL-42	Labeling		Label is not available on this site.
12/19/1983	SUPPL-41	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/17/1983	SUPPL-40	Manufacturing (CMC)-Control		Label is not available on this site.
08/12/1980	SUPPL-37	Manufacturing (CMC)		Label is not available on this site.
06/18/1980	SUPPL-36	Manufacturing (CMC)-Formulation		Label is not available on this site.
09/13/1979	SUPPL-35	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/05/1977	SUPPL-34	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/26/1977	SUPPL-33	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/02/1977	SUPPL-32	Labeling		Label is not available on this site.
04/29/1977	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/1978	SUPPL-30	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/14/1977	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
12/14/1977	SUPPL-28	Unspecified		Label is not available on this site.
08/22/1975	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
01/06/1975	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
11/08/1974	SUPPL-22	Labeling		Label is not available on this site.
08/02/1974	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
08/02/1974	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.