Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070345
Company: RISING

Products on ANDA 070345

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070345

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/1985	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-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/08/2021	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
02/06/2019	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/15/2015	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/28/2010	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2002	SUPPL-11	Labeling		Label is not available on this site.
02/25/1998	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
02/05/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/19/1993	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/29/1993	SUPPL-6	Labeling		Label is not available on this site.
01/31/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/16/1989	SUPPL-4	Labeling		Label is not available on this site.
02/18/1988	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 070345

FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	072369	CHARTWELL RX
FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	070345	RISING

CAPSULE;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	15MG	CAPSULE;ORAL	Prescription	No	AB	072368	CHARTWELL RX
FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE	15MG	CAPSULE;ORAL	Prescription	No	AB	070345	RISING