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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071415
Company: HIKMA

Products on ANDA 071415

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071415

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/1987	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
01/17/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
02/05/2021	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
07/27/2020	SUPPL-16	Labeling-Container/Carton Labels		Label is not available on this site.
05/02/2016	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/20/2001	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/21/2000	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/09/1998	SUPPL-7	Labeling		Label is not available on this site.
08/28/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/09/1994	SUPPL-5	Labeling		Label is not available on this site.
06/11/1990	SUPPL-4	Labeling		Label is not available on this site.
04/20/1989	SUPPL-2	Bioequivalence		Label is not available on this site.
01/26/1990	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 071415

DIAZEPAM INTENSOL

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

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