Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011673
Company: 3M
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEPANIL DIETHYLPROPION HYDROCHLORIDE 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
08/14/1959 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
06/16/1987 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/17/1987 SUPPL-11 Labeling

Label is not available on this site.

02/13/1985 SUPPL-10 Labeling

Label is not available on this site.

09/09/1975 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

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