Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018924
Company: HOSPIRA

Products on NDA 018924

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	AMINOPHYLLINE	100MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	AMINOPHYLLINE	200MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	AMINOPHYLLINE	400MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	AMINOPHYLLINE	500MG/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018924

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/1984	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
11/10/1998	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
07/10/1997	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
04/02/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
07/22/1996	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/13/1996	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/09/1996	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
07/09/1996	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
07/13/1992	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/02/1991	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/05/1992	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/1990	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
06/05/1992	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
11/26/1986	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
08/08/1986	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1986	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1986	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
06/10/1985	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
01/31/1986	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.