Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073095
Company: TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLEMASTINE FUMARATE CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML SYRUP;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
04/21/1992 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
03/23/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/08/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/13/1998 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/20/1994 SUPPL-6 Labeling

Label is not available on this site.

08/15/1995 SUPPL-5 Labeling

Label is not available on this site.

08/15/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/15/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/23/1994 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