Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212046
Company: PROVEPHARM SAS

Products on ANDA 212046

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 212046

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212046

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 PHARMA LTD
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	040475	PADAGIS US
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	212046	PROVEPHARM SAS
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	207264	SAGENT PHARMS INC