Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076130
Company: DAVA PHARMS INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VOSPIRE ER ALBUTEROL SULFATE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
VOSPIRE ER ALBUTEROL SULFATE EQ 8MG 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
09/30/2002 ORIG-1 Approval Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/076130_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/09/2007 SUPPL-10 Labeling

Label is not available on this site.
08/15/2006 SUPPL-6 Labeling

Label is not available on this site.
01/16/2004 SUPPL-2 Labeling

Label is not available on this site.

VOSPIRE ER

TABLET, EXTENDED RELEASE;ORAL; EQ 4MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078092 MYLAN
VOSPIRE ER ALBUTEROL SULFATE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076130 DAVA PHARMS INC

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