Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020393
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROVENT IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED;NASAL Prescription AB 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
10/20/1995 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
05/11/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/05/2015 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

02/02/2011 SUPPL-11 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020393s011ltr.pdf
12/04/2007 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020393s007,020394s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020393s007,020394s008ltr.pdf
05/23/2003 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20393slr004,20394slr005_atrovent_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr005ltr.pdf
08/18/1999 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/01/1998 SUPPL-1 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20393ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2007 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020393s007,020394s008lbl.pdf
05/23/2003 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20393slr004,20394slr005_atrovent_lbl.pdf

ATROVENT

SPRAY, METERED;NASAL; 0.021MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATROVENT IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020393 BOEHRINGER INGELHEIM
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076025 BAUSCH AND LOMB
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 075552 MYLAN SPECIALITY LP
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.021MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076664 WEST-WARD PHARMS INT

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