Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016912
Company: ROCHE
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
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.

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