Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020503
Company: 3M DRUG DELIVERY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVENTIL-HFA ALBUTEROL SULFATE EQ 0.09MG BASE/INH AEROSOL, METERED;INHALATION Prescription BX 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
08/15/1996 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/22/2017 SUPPL-54 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020503s054lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020503Orig1s054ltr.pdf
11/09/2016 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

03/03/2016 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

02/12/2016 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

02/03/2015 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

02/25/2013 SUPPL-47 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020503Orig1s047.pdf
06/05/2012 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020503s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020503s046ltr.pdf
09/08/2009 SUPPL-39 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020503s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020503s039ltr.pdf
01/29/2004 SUPPL-22 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20503slr022ltr.pdf
07/26/2002 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/17/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

04/17/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/10/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/18/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/2000 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2000 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2000 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1999 SUPPL-11 Efficacy-New Indication Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20503s11ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20503-S011_Proventil.pdf
08/18/1999 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1999 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/1998 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

02/05/1998 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1998 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20503s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20503s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20503-S004_Proventil.pdf
08/18/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/22/1997 SUPPL-2 Labeling

Label is not available on this site.

12/26/1996 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
09/22/2017 SUPPL-54 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020503s054lbl.pdf
06/05/2012 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020503s046lbl.pdf
09/08/2009 SUPPL-39 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020503s039lbl.pdf
09/23/1998 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20503s4lbl.pdf

PROVENTIL-HFA

There are no Therapeutic Equivalents.

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