Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078214
Company: LANNETT

Products on ANDA 078214

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DANAZOL	DANAZOL	50MG	CAPSULE;ORAL	Prescription	AB	No	No
DANAZOL	DANAZOL	100MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078214

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2007	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
03/15/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
10/29/2007	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078214

DANAZOL

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DANAZOL	DANAZOL	50MG	CAPSULE;ORAL	Prescription	No	AB	074582	BARR
DANAZOL	DANAZOL	50MG	CAPSULE;ORAL	Prescription	No	AB	078214	LANNETT
DANAZOL	DANAZOL	50MG	CAPSULE;ORAL	Prescription	No	AB	077246	LANNETT CO INC

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DANAZOL	DANAZOL	100MG	CAPSULE;ORAL	Prescription	No	AB	074582	BARR
DANAZOL	DANAZOL	100MG	CAPSULE;ORAL	Prescription	No	AB	078214	LANNETT
DANAZOL	DANAZOL	100MG	CAPSULE;ORAL	Prescription	No	AB	077246	LANNETT CO INC