Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020250
Company: GLAXOSMITHKLINE

Products on NDA 020250

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HALFAN	HALOFANTRINE HYDROCHLORIDE	250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020250

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/1992	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2002	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20250slr007,008ltr.pdf
08/01/2002	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20250slr007,008ltr.pdf
08/06/1997	SUPPL-6	Labeling		Label is not available on this site.
09/23/1993	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/12/1993	SUPPL-3	Labeling		Label is not available on this site.
08/06/1997	SUPPL-2	Labeling		Label is not available on this site.
12/02/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020250

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/01/2002	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf
08/01/2002	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20250s7s8lbl.pdf