Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085916
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIETHYLPROPION HYDROCHLORIDE 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
09/16/1994 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/1989 SUPPL-18 Bioequivalence

Label is not available on this site.

10/20/1982 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/02/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/02/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/02/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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