Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019604
Company: MURO
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 No No
VOLMAX ALBUTEROL SULFATE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
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.

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