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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207484
Company: MIKART

Products on ANDA 207484

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CARBINOXAMINE MALEATE	CARBINOXAMINE MALEATE	6MG	TABLET;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207484

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207484

CARBINOXAMINE MALEATE

TABLET;ORAL; 6MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBINOXAMINE MALEATE	CARBINOXAMINE MALEATE	6MG	TABLET;ORAL	Prescription	No	AA	215476	LEADING
CARBINOXAMINE MALEATE	CARBINOXAMINE MALEATE	6MG	TABLET;ORAL	Prescription	No	AA	207484	MIKART

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