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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073664
Company: HOSPIRA
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
08/30/1994 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
01/15/2016 SUPPL-18 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

08/05/1998 SUPPL-6 Labeling

Label is not available on this site.

02/05/1996 SUPPL-4 Labeling

Label is not available on this site.

02/05/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/05/1996 SUPPL-1 Manufacturing (CMC)

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
ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION;INHALATION, ORAL Prescription No AN 072489 AM REGENT
ACETYLCYSTEINE ACETYLCYSTEINE 10% SOLUTION;INHALATION, ORAL Prescription No AN 073664 HOSPIRA
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