An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204380
Company: ACTAVIS LLC

Products on ANDA 204380

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204380

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2017	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2025	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
04/09/2025	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204380

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	206505	NOVITIUM PHARMA
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	No	AB	207165	RISING
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	No	AB	203887	SOLIS PHARMS
DAPSONE	DAPSONE	25MG	TABLET;ORAL	Prescription	No	AB	220103	ZYDUS LIFESCIENCES

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	206505	NOVITIUM PHARMA
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	No	AB	207165	RISING
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	No	AB	203887	SOLIS PHARMS
DAPSONE	DAPSONE	100MG	TABLET;ORAL	Prescription	No	AB	220103	ZYDUS LIFESCIENCES

Top