Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087727
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLINE DYE FREE AMINOPHYLLINE 105MG/5ML SOLUTION;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
04/16/1982 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
11/13/2000 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/05/1997 SUPPL-17 Labeling

Label is not available on this site.

07/26/1996 SUPPL-16 Labeling

Label is not available on this site.

12/03/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/28/1990 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/05/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/04/1990 SUPPL-12 Labeling

Label is not available on this site.

05/16/1990 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/19/1989 SUPPL-10 Labeling

Label is not available on this site.

10/02/1989 SUPPL-9 Labeling

Label is not available on this site.

05/31/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/09/1988 SUPPL-7 Labeling

Label is not available on this site.

08/14/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/14/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/06/1989 SUPPL-4 Labeling

Label is not available on this site.

04/17/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/17/1983 SUPPL-2 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