Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 002386
Company: GD SEARLE LLC

Products on NDA 002386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOPHYLLIN	AMINOPHYLLINE	100MG	TABLET;ORAL	Discontinued	None	No	No
AMINOPHYLLIN	AMINOPHYLLINE	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 002386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/1940	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
08/27/1991	SUPPL-15	Labeling		Label is not available on this site.
08/14/1989	SUPPL-14	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/27/1991	SUPPL-13	Labeling		Label is not available on this site.
08/27/1991	SUPPL-12	Labeling		Label is not available on this site.
12/09/1983	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
04/14/1981	SUPPL-10	Labeling		Label is not available on this site.
04/14/1981	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/23/1980	SUPPL-8	Labeling		Label is not available on this site.
06/13/1980	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
06/13/1980	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
09/15/1980	SUPPL-5	Labeling		Label is not available on this site.
01/18/1980	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/01/1977	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
08/01/1977	SUPPL-2	Labeling		Label is not available on this site.
08/01/1977	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.