Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020949
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACCUNEB ALBUTEROL SULFATE EQ 0.042% BASE SOLUTION;INHALATION Prescription AN Yes Yes
ACCUNEB ALBUTEROL SULFATE EQ 0.021% BASE SOLUTION;INHALATION Prescription AN Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/30/2001 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-949_AccuNeb.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

09/30/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/02/2011 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020949s024ltr.pdf
06/02/2006 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020949s011LTR.pdf
11/13/2002 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/20/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/02/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf

ACCUNEB

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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