Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016033
Company: GLAXOSMITHKLINE

Products on NDA 016033

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016033

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.

Labels for NDA 016033

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