Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 083283
Company: HOSPIRA

Products on ANDA 083283

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.02MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 083283

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/15/1974	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
01/29/1997	SUPPL-34	Labeling		Label is not available on this site.
03/08/2000	SUPPL-33	Labeling		Label is not available on this site.
02/23/1995	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
06/01/1992	SUPPL-31	Labeling		Label is not available on this site.
02/05/1991	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
03/24/1989	SUPPL-26	Labeling		Label is not available on this site.
07/26/1989	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
06/03/1988	SUPPL-24	Labeling		Label is not available on this site.
04/04/1988	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
04/04/1988	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/13/1986	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/13/1986	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/13/1986	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/03/1984	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
10/05/1982	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.