Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075562
Company: NEPHRON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Prescription AN 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
09/27/2001 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75562.ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/075562.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/29/2007 SUPPL-1 Labeling

Label is not available on this site.

IPRATROPIUM BROMIDE

SOLUTION;INHALATION; 0.02%
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Prescription No AN 206543 AUROBINDO PHARMA LTD
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Prescription No AN 077072 LANDELA PHARM
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Prescription No AN 075562 NEPHRON
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Prescription No AN 075693 RITEDOSE CORP
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Prescription No AN 207903 SUN PHARM
IPRATROPIUM BROMIDE IPRATROPIUM BROMIDE 0.02% SOLUTION;INHALATION Prescription No AN 076291 WATSON LABS

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