Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071620
Company: ACTAVIS ELIZABETH

Products on ANDA 071620

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	AB	No	No
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071620

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/1987	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
11/18/2023	SUPPL-45	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/09/2022	SUPPL-42	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/09/2022	SUPPL-40	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/30/2019	SUPPL-38	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/30/2019	SUPPL-37	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/31/2009	SUPPL-28	Labeling		Label is not available on this site.
12/12/2002	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
11/02/2001	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
02/01/2001	SUPPL-13	Labeling		Label is not available on this site.
01/18/1996	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
07/09/1993	SUPPL-11	Labeling		Label is not available on this site.
12/28/1992	SUPPL-10	Labeling		Label is not available on this site.
10/21/1992	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/21/1990	SUPPL-8	Bioequivalence		Label is not available on this site.
09/25/1991	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/07/1989	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
12/20/1988	SUPPL-2	Labeling		Label is not available on this site.
10/05/1987	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 071620

TEMAZEPAM

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RESTORIL	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	Yes	AB	018163	SPECGX LLC
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071620	ACTAVIS ELIZABETH
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	211542	ALEMBIC
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	217875	ALKEM LABS LTD
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	203482	AMNEAL PHARMS
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071428	CHARTWELL RX
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	071457	NOVEL LABS INC
TEMAZEPAM	TEMAZEPAM	30MG	CAPSULE;ORAL	Prescription	No	AB	201781	PRINSTON INC

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RESTORIL	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	Yes	AB	018163	SPECGX LLC
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	071620	ACTAVIS ELIZABETH
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	211542	ALEMBIC
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	217875	ALKEM LABS LTD
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	203482	AMNEAL PHARMS
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	071427	CHARTWELL RX
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	071456	NOVEL LABS INC
TEMAZEPAM	TEMAZEPAM	15MG	CAPSULE;ORAL	Prescription	No	AB	201781	PRINSTON INC