Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076155
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED;NASAL Prescription AB 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
04/18/2003 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/18/2015 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

03/24/2009 SUPPL-15 Labeling

Label is not available on this site.

05/22/2007 SUPPL-11 Labeling

Label is not available on this site.

IPRATROPIUM BROMIDE

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
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.042MG/SPRAY SPRAY, METERED;NASAL Prescription No AB 076155 APOTEX INC
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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