Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072547
Company: LUITPOLD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETYLCYSTEINE ACETYLCYSTEINE 20% SOLUTION;INHALATION, ORAL Prescription AN No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/28/1995 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
04/12/2001 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/30/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/23/1998 SUPPL-3 Labeling

Label is not available on this site.

11/04/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/13/1998 SUPPL-1 Labeling

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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