Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203853
Company: ALVOGEN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION;INHALATION, ORAL 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
06/21/2012 ORIG-1 Approval

Label is not available on this site.

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL; 20%
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION;INHALATION, ORAL Prescription No AN 203853 ALVOGEN INC
ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION;INHALATION, ORAL Prescription No AN 074037 HOSPIRA
ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION;INHALATION, ORAL Prescription No AN 072547 LUITPOLD

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