Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070575
Company: DEY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUCOSIL-10 ACETYLCYSTEINE 10% SOLUTION;INHALATION, ORAL Discontinued None 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
10/14/1986 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
03/21/2000 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/2000 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/2001 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/25/1999 SUPPL-23 Labeling

Label is not available on this site.

11/25/1998 SUPPL-20 Labeling

Label is not available on this site.

02/20/1998 SUPPL-19 Labeling

Label is not available on this site.

09/05/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/11/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/29/1992 SUPPL-15 Labeling

Label is not available on this site.

10/26/1990 SUPPL-14 Labeling

Label is not available on this site.

08/01/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/20/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/29/1988 SUPPL-10 Labeling

Label is not available on this site.

04/20/1988 SUPPL-6 Labeling

Label is not available on this site.

01/22/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/16/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/16/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/16/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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