Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016245
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERCYTE PIPOBROMAN 10MG TABLET;ORAL Discontinued None No No
VERCYTE PIPOBROMAN 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
07/01/1966 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
04/22/1988 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/22/1984 SUPPL-2 Labeling

Label is not available on this site.

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