Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206505
Company: NOVITIUM PHARMA

Products on ANDA 206505

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	AB	No	No
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206505

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 206505

DAPSONE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	No	AB	204380	ACTAVIS LLC
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	Yes	AB	086841	EVEREST LIFE SCI
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	No	AB	203887	NOSTRUM LABS INC
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	No	AB	206505	NOVITIUM PHARMA
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	No	AB	207165	RISING

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	No	AB	204380	ACTAVIS LLC
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	Yes	AB	086842	EVEREST LIFE SCI
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	No	AB	203887	NOSTRUM LABS INC
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	No	AB	206505	NOVITIUM PHARMA
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	No	AB	207165	RISING