Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203139
Company: TWI PHARMS

Products on ANDA 203139

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEGESTROL ACETATE	MEGESTROL ACETATE	125MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203139

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/27/2014	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
02/21/2020	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
06/08/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203139

MEGESTROL ACETATE

SUSPENSION;ORAL; 125MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEGACE ES	MEGESTROL ACETATE	125MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	021778	ENDO OPERATIONS
MEGESTROL ACETATE	MEGESTROL ACETATE	125MG/ML	SUSPENSION;ORAL	Prescription	No	AB	203139	TWI PHARMS