Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086842
Company: EVEREST LIFE SCI

Products on ANDA 086842

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086842

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/03/1979	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
08/24/2009	SUPPL-18	Labeling		Label is not available on this site.
08/19/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
07/13/1988	SUPPL-12	Labeling		Label is not available on this site.
07/13/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/02/1983	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
05/04/1982	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/04/1982	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 086842

DAPSONE

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