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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084088
Company: LANNETT

Products on ANDA 084088

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VELTANE	BROMPHENIRAMINE MALEATE	4MG	Tablet; Oral	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084088

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1974	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 084088

VELTANE

Tablet; Oral; 4MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BROMPHENIRAMINE MALEATE	BROMPHENIRAMINE MALEATE	4MG	Tablet; Oral	Prescription	No	AA	085592	NYLOS
BROMPHENIRAMINE MALEATE	BROMPHENIRAMINE MALEATE	4MG	Tablet; Oral	Prescription	No	AA	085521	PHOENIX LABS NY
VELTANE	BROMPHENIRAMINE MALEATE	4MG	Tablet; Oral	Prescription	No	AA	084088	LANNETT

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