Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075671
Company: STRIDES PHARMA INTL

Products on ANDA 075671

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075671

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/2001	ORIG-1	Approval			Letter (PDF) Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol%20Acetate.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75671ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-671_Megestrol%20Acetate.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/19/2020	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
01/16/2013	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
05/04/2004	SUPPL-11	Labeling		Label is not available on this site.
02/23/2004	SUPPL-8	Labeling		Label is not available on this site.
08/14/2003	SUPPL-7	Labeling		Label is not available on this site.
10/01/2002	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 075671

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