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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211393
Company: HIKMA

Products on ANDA 211393

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211393

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211393Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 211393

DIHYDROERGOTAMINE MESYLATE

SPRAY, METERED;NASAL; 0.5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	212907	CIPLA
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	211393	HIKMA
DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	No	AB	216881	RUBICON
MIGRANAL	DIHYDROERGOTAMINE MESYLATE	0.5MG/SPRAY	SPRAY, METERED;NASAL	Prescription	Yes	AB	020148	BAUSCH

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