Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077772
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION;INHALATION Prescription AN No No
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 0.042% 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
09/25/2007 ORIG-1 Approval

Label is not available on this site.

ALBUTEROL SULFATE

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

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

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