Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018297
Company: ABBOTT

Products on NDA 018297

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOPURIN	ALLOPURINOL	100MG	TABLET;ORAL	Discontinued	None	No	No
LOPURIN	ALLOPURINOL	300MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018297

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/1980	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
07/21/1986	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/18/1986	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/31/1985	SUPPL-13	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/18/1985	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/06/1985	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
01/31/1986	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
03/25/1981	SUPPL-7	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/15/1985	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/10/1981	SUPPL-4	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/11/1982	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/11/1982	SUPPL-2	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/27/1981	SUPPL-1	Labeling		Label is not available on this site.