Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 010375
Company: 3M

Products on NDA 010375

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOPROTERENOL HYDROCHLORIDE	ISOPROTERENOL HYDROCHLORIDE	0.12MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No
MEDIHALER-ISO	ISOPROTERENOL SULFATE	0.08MG/INH	AEROSOL, METERED;INHALATION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010375

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/1956	ORIG-1	Approval	Type 2 - New Active Ingredient	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
12/30/1997	SUPPL-23	Labeling		Label is not available on this site.
12/20/1993	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/15/1987	SUPPL-21	Labeling		Label is not available on this site.
02/17/1987	SUPPL-20	Labeling		Label is not available on this site.
03/05/1982	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/2009	SUPPL-17	Labeling		Label is not available on this site.
09/18/1978	SUPPL-16	Manufacturing (CMC)-Control		Label is not available on this site.
04/13/1978	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1976	SUPPL-14	Labeling		Label is not available on this site.
07/29/1975	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1975	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1975	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.