Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072368
Company: CHARTWELL RX

Products on ANDA 072368

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072368

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/1989	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-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/08/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/06/2019	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/17/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/23/1997	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/23/1993	SUPPL-2	Labeling		Label is not available on this site.
05/09/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072368

FLURAZEPAM HYDROCHLORIDE

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