Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204433
Company: CHARTWELL MOLECULAR

Products on ANDA 204433

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	5MG/ML	CONCENTRATE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204433

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/14/2014	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-9	Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/04/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
03/24/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204433

DIAZEPAM

CONCENTRATE;ORAL; 5MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIAZEPAM	DIAZEPAM	5MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	204433	CHARTWELL MOLECULAR
DIAZEPAM INTENSOL	DIAZEPAM	5MG/ML	CONCENTRATE;ORAL	Prescription	No	AA	071415	HIKMA