Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012427
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIDREX BENZPHETAMINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
DIDREX BENZPHETAMINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/26/1960 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
02/05/2010 SUPPL-26 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012427s026ltr.pdf
09/23/1998 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/31/1992 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/2000 SUPPL-21 Labeling

Label is not available on this site.

07/27/2000 SUPPL-20 Labeling

Label is not available on this site.

12/31/1985 SUPPL-19 Labeling

Label is not available on this site.

09/04/1984 SUPPL-18 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/05/2010 SUPPL-26 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012427s026lbl.pdf

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