Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016913
Company: SHIRE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOPAR LEVODOPA 250MG CAPSULE;ORAL Discontinued None No No
DOPAR LEVODOPA 500MG CAPSULE;ORAL Discontinued None No No
DOPAR LEVODOPA 100MG CAPSULE;ORAL Discontinued None No No
DOPAR LEVODOPA 250MG TABLET;ORAL Discontinued None No No
DOPAR LEVODOPA 500MG 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
06/04/1970 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
05/05/1992 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

12/29/1989 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/23/1986 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1983 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1983 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1983 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1983 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

03/30/1983 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/1977 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/14/1977 SUPPL-19 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/30/1976 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/27/1975 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

02/27/1975 SUPPL-15 Efficacy

Label is not available on this site.

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