Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087242
Company: HOSPIRA

Products on ANDA 087242

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMINOPHYLLINE	AMINOPHYLLINE	25MG/ML	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/1983	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
02/24/1997	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/03/1996	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/31/1996	SUPPL-13	Labeling		Label is not available on this site.
12/22/1993	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
08/28/1992	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
03/05/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/05/1992	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/05/1992	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
03/05/1992	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/01/1995	SUPPL-5	Labeling		Label is not available on this site.
05/07/1990	SUPPL-4	Labeling		Label is not available on this site.
04/09/1991	SUPPL-3	Labeling		Label is not available on this site.
12/27/1989	SUPPL-2	Labeling		Label is not available on this site.