Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076355
Company: NEPHRON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION;INHALATION Prescription AN No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION;INHALATION Prescription AN 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
06/28/2004 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/13/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

03/31/2010 SUPPL-7 Labeling

Label is not available on this site.

03/29/2007 SUPPL-4 Labeling

Label is not available on this site.

03/22/2005 SUPPL-1 Labeling

Label is not available on this site.

ALBUTEROL SULFATE

SOLUTION;INHALATION; EQ 0.042% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCUNEB ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION;INHALATION Prescription Yes AN 020949 MYLAN SPECIALITY LP
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 076355 NEPHRON
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION;INHALATION Prescription No AN 077772 WATSON LABS

SOLUTION;INHALATION; EQ 0.021% BASE
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACCUNEB ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION;INHALATION Prescription Yes AN 020949 MYLAN SPECIALITY LP
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 076355 NEPHRON
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION;INHALATION Prescription No AN 077772 WATSON LABS

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