Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087324
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE 0.2% SOLUTION;INHALATION 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
04/08/1981 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
08/28/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/15/1991 SUPPL-16 Labeling

Label is not available on this site.

10/12/1990 SUPPL-15 Labeling

Label is not available on this site.

01/27/1992 SUPPL-14 Labeling

Label is not available on this site.

02/16/1990 SUPPL-13 Labeling

Label is not available on this site.

01/17/1989 SUPPL-8 Labeling

Label is not available on this site.

11/14/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/14/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/19/1988 SUPPL-5 Bioequivalence

Label is not available on this site.

01/14/1983 SUPPL-4 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