Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 072938
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALBUTEROL SULFATE ALBUTEROL SULFATE EQ 2MG BASE TABLET;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
03/30/1990 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
08/30/2001 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

06/12/1998 SUPPL-24 Labeling

Label is not available on this site.

03/09/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

11/26/1996 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/13/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/25/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/02/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/19/1993 SUPPL-5 Labeling

Label is not available on this site.

05/25/1993 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/30/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/19/1990 SUPPL-1 Labeling

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