Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072123
Company: AM REGENT

Products on ANDA 072123

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DROPERIDOL	DROPERIDOL	2.5MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072123

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/1988	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
02/21/2023	SUPPL-22	Labeling-Container/Carton Labels		Label is not available on this site.
01/10/2002	SUPPL-12	Labeling		Label is not available on this site.
03/25/1999	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/02/1998	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/17/1995	SUPPL-5	Labeling		Label is not available on this site.
02/28/1996	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
10/11/1994	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/26/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 072123

DROPERIDOL

INJECTABLE;INJECTION; 2.5MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DROPERIDOL	DROPERIDOL	2.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	072123	AM REGENT
DROPERIDOL	DROPERIDOL	2.5MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	208197	HIKMA