Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 019604
Company: MURO

Products on NDA 019604

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VOLMAX	ALBUTEROL SULFATE	EQ 8MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
VOLMAX	ALBUTEROL SULFATE	EQ 4MG BASE	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019604

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/1992	ORIG-1	Approval	Type 3 - New Dosage Form	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
11/28/2001	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/03/1999	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
09/03/1999	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/27/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/07/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/08/1997	SUPPL-8	Efficacy-New Patient Population		Label is not available on this site.
11/20/1997	SUPPL-7	Labeling		Label is not available on this site.
03/25/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/20/1995	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
07/06/1995	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/06/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
07/25/1994	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
09/21/1994	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.