Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077404
Company: NOVITIUM PHARMA

Products on ANDA 077404

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077404

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2006	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
02/29/2016	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/17/2008	SUPPL-5	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077404

MEGESTROL ACETATE

SUSPENSION;ORAL; 40MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	077404	NOVITIUM PHARMA
MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	076721	PHARMOBEDIENT
MEGESTROL ACETATE	MEGESTROL ACETATE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	075671	STRIDES PHARMA INTL