Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020394
Company: BOEHRINGER INGELHEIM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ATROVENT IPRATROPIUM BROMIDE 0.042MG/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
02/18/2011 SUPPL-12 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020394s012ltr.pdf
10/14/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020394s008ltr.pdf
05/23/2003 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020394s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr005ltr.pdf
10/27/2000 SUPPL-4 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020394 Orig1s004.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.

11/09/1998 SUPPL-1 Efficacy-New Indication Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20394s01ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20394-S001_Atrovent.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/23/2003 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020394s005lbl.pdf

ATROVENT

SPRAY, METERED;NASAL; 0.042MG/SPRAY
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATROVENT IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED;NASAL Prescription Yes AB 020394 BOEHRINGER INGELHEIM
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076103 BAUSCH AND LOMB
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 075553 MYLAN SPECIALITY LP
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076598 WEST-WARD PHARMS INT

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