Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071134
Company: MAYNE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription AB 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
02/03/1987 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
03/09/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

08/06/2008 SUPPL-21 Labeling

Label is not available on this site.

04/25/2001 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/21/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/02/1993 SUPPL-10 Labeling

Label is not available on this site.

01/28/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/07/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/04/1988 SUPPL-4 Labeling

Label is not available on this site.

08/11/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

DIAZEPAM

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 070152 BARR
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 071307 IVAX SUB TEVA PHARMS
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 071134 MAYNE PHARMA
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 070325 MYLAN
DIAZEPAM DIAZEPAM 2MG TABLET;ORAL Prescription No AB 077749 VINTAGE PHARMS
VALIUM DIAZEPAM 2MG TABLET;ORAL Prescription Yes AB 013263 ROCHE

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