Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204674
Company: ALVOGEN INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETYLCYSTEINE ACETYLCYSTEINE 10% 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
02/11/2014 ORIG-1 Approval STANDARD

Label is not available on this site.

ACETYLCYSTEINE

SOLUTION;INHALATION, ORAL; 10%
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION;INHALATION, ORAL Prescription No AN 204674 ALVOGEN INC
ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION;INHALATION, ORAL Prescription No AN 073664 HOSPIRA
ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION;INHALATION, ORAL Prescription No AN 072489 LUITPOLD

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