Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040453
Company: HIKMA

Products on ANDA 040453

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040453

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/09/2003	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/040453.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2023	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 040453

DIHYDROERGOTAMINE MESYLATE

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	215623	GLAND
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	040453	HIKMA
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	206621	HIKMA PHARMS
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212046	MILLA PHARMS
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207264	SAGENT PHARMS INC