Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018342
Company: GLAXOSMITHKLINE

Products on NDA 018342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
WELLCOVORIN	LEUCOVORIN CALCIUM	EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
WELLCOVORIN	LEUCOVORIN CALCIUM	EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/08/1983	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; 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
03/09/2026	SUPPL-15	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018342s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/018342Orig1s015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/018342Orig1s015Unireview.pdf
06/06/1996	SUPPL-14	Labeling		Label is not available on this site.
04/14/1993	SUPPL-8	Labeling		Label is not available on this site.

Labels for NDA 018342

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/09/2026	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/018342s015lbl.pdf