Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204851
Company: IMPAX LABS INC

Products on ANDA 204851

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLTESTOSTERONE	METHYLTESTOSTERONE	10MG	CAPSULE;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204851

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/21/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 204851

METHYLTESTOSTERONE

CAPSULE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLTESTOSTERONE	METHYLTESTOSTERONE	10MG	CAPSULE;ORAL	Prescription	No	AB	204851	IMPAX LABS INC
METHYLTESTOSTERONE	METHYLTESTOSTERONE	10MG	CAPSULE;ORAL	Prescription	No	AB	215270	NOVITIUM PHARMA