Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072253
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription AB No Yes
OXAZEPAM OXAZEPAM 10MG CAPSULE;ORAL Prescription AB No No
OXAZEPAM OXAZEPAM 15MG 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
04/14/1988 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-34 Labeling-Package Insert

Label is not available on this site.

10/18/2002 SUPPL-9 Labeling

Label is not available on this site.

11/02/2001 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

08/02/2000 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2000 SUPPL-6 Labeling

Label is not available on this site.

02/20/1998 SUPPL-5 Labeling

Label is not available on this site.

01/18/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/31/1993 SUPPL-3 Labeling

Label is not available on this site.

06/10/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

OXAZEPAM

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription No AB 072253 ACTAVIS ELIZABETH
OXAZEPAM OXAZEPAM 30MG CAPSULE;ORAL Prescription No AB 071814 SANDOZ

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

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
OXAZEPAM OXAZEPAM 15MG CAPSULE;ORAL Prescription No AB 072253 ACTAVIS ELIZABETH
OXAZEPAM OXAZEPAM 15MG CAPSULE;ORAL Prescription No AB 071756 SANDOZ

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