Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072253
Company: ACTAVIS ELIZABETH

Products on ANDA 072253

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072253

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
01/17/2023	SUPPL-43	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/14/2022	SUPPL-42	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-39	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 072253

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	EPIC PHARMA LLC
OXAZEPAM	OXAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071026	UNITED RES LABS

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	EPIC PHARMA LLC
OXAZEPAM	OXAZEPAM	10MG	CAPSULE;ORAL	Prescription	No	AB	071026	UNITED RES LABS

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	EPIC PHARMA LLC
OXAZEPAM	OXAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	071026	UNITED RES LABS