Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213465
Company: PADAGIS ISRAEL

Products on ANDA 213465

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	AB	No	No
SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213465

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213465

SUMATRIPTAN

SPRAY;NASAL; 20MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	Yes	AB	020626	GLAXOSMITHKLINE
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	214209	CIPLA
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	204841	LANNETT CO INC
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	213465	PADAGIS ISRAEL
SUMATRIPTAN	SUMATRIPTAN	20MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	208967	REGCON HOLDINGS

SPRAY;NASAL; 5MG/SPRAY
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IMITREX	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	Yes	AB	020626	GLAXOSMITHKLINE
SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	204841	LANNETT CO INC
SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	213465	PADAGIS ISRAEL
SUMATRIPTAN	SUMATRIPTAN	5MG/SPRAY	SPRAY;NASAL	Prescription	No	AB	213650	PERRIGO UK FINCO