Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089892
Company: ACTAVIS MID ATLANTIC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;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
09/25/1992 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
03/10/2004 SUPPL-17 Labeling

Label is not available on this site.

11/13/2001 SUPPL-12 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

11/02/2000 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/2000 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/18/2000 SUPPL-8 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/09/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/09/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/07/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/07/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/07/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/07/1996 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