Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078092
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 4MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
01/29/2007 ORIG-1 Approval

Label is not available on this site.

ALBUTEROL SULFATE

TABLET, EXTENDED RELEASE;ORAL; EQ 8MG 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 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 078092 MYLAN
VOSPIRE ER ALBUTEROL SULFATE EQ 8MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076130 DAVA PHARMS INC

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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