Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 016033
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VONTROL DIPHENIDOL HYDROCHLORIDE EQ 25MG BASE 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
04/05/1967 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
08/06/2001 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16033s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16033s11ltr.pdf
03/13/2009 SUPPL-10 Labeling

Label is not available on this site.

03/13/2009 SUPPL-9 Labeling

Label is not available on this site.

03/13/2009 SUPPL-8 Labeling

Label is not available on this site.

09/05/1980 SUPPL-7 Labeling

Label is not available on this site.

09/05/1980 SUPPL-6 Labeling

Label is not available on this site.

06/06/1986 SUPPL-5 Labeling

Label is not available on this site.

03/13/2009 SUPPL-4 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/06/2001 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/16033s11lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English