Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010653
Company: 3M
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DISIPAL ORPHENADRINE HYDROCHLORIDE 50MG 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
05/10/1957 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/28/1980 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/29/1977 SUPPL-10 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/22/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

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