Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207875
Company: SUN PHARMA GLOBAL
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;0.17% 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
08/07/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

SOLUTION;INHALATION; EQ 0.083% BASE;0.17%
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;0.17% SOLUTION;INHALATION Prescription No AN 207875 SUN PHARMA GLOBAL

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