Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070576
Company: DEY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MUCOSIL-20 ACETYLCYSTEINE 20% 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-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/2000 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/2001 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/25/1999 SUPPL-27 Labeling

Label is not available on this site.

11/25/1998 SUPPL-24 Labeling

Label is not available on this site.

02/20/1998 SUPPL-23 Labeling

Label is not available on this site.

09/05/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/24/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/11/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/29/1992 SUPPL-19 Labeling

Label is not available on this site.

10/26/1990 SUPPL-17 Labeling

Label is not available on this site.

07/19/1990 SUPPL-16 Labeling

Label is not available on this site.

08/01/1989 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/01/1989 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/01/1989 SUPPL-13 Labeling

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-4 Labeling

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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English