Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010124
Company: LANNETT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SERPALAN RESERPINE 0.1MG TABLET;ORAL Discontinued None No No
SERPALAN RESERPINE 0.25MG 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
10/12/1955 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
09/15/1987 SUPPL-6 Labeling

Label is not available on this site.

06/08/1984 SUPPL-5 Labeling

Label is not available on this site.

09/28/1977 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

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