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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076749
Company: NEPHRON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION;INHALATION Prescription AN No Yes
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE 0.5MG; 0.017% SOLUTION; INHALATION Prescription None 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
12/31/2007 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
08/13/2012 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/13/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

09/16/2008 SUPPL-1 Labeling

Label is not available on this site.

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

SOLUTION;INHALATION; EQ 0.083% BASE;0.017%
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION;INHALATION Prescription No AN 077559 CIPLA
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION;INHALATION Prescription No AN 076749 NEPHRON
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION;INHALATION Prescription No AN 202496 RITEDOSE CORP
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE ALBUTEROL SULFATE; IPRATROPIUM BROMIDE EQ 0.083% BASE;0.017% SOLUTION;INHALATION Prescription No AN 207875 SUN PHARM

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

There are no Therapeutic Equivalents.

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