Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071813
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXAZEPAM OXAZEPAM 10MG CAPSULE;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
04/19/1988 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
12/16/2016 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/20/2015 SUPPL-14 Labeling

Label is not available on this site.

11/01/2002 SUPPL-10 Labeling

Label is not available on this site.

11/06/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2001 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/09/1998 SUPPL-6 Labeling

Label is not available on this site.

03/28/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/14/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/14/1993 SUPPL-3 Labeling

Label is not available on this site.

04/27/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/12/1989 SUPPL-1 Labeling

Label is not available on this site.

OXAZEPAM

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription No AB 072253 ACTAVIS ELIZABETH
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription No AB 071813 SANDOZ

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