Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072423
Company: STRIDES PHARMA INTL

Products on ANDA 072423

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072423

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/08/1988	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
08/06/2004	SUPPL-17	Labeling		Label is not available on this site.
08/29/2003	SUPPL-16	Labeling		Label is not available on this site.
12/12/2001	SUPPL-15	Labeling		Label is not available on this site.
10/11/2001	SUPPL-14	Labeling		Label is not available on this site.
10/11/2001	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
10/13/2000	SUPPL-12	Labeling		Label is not available on this site.
06/27/2000	SUPPL-11	Labeling		Label is not available on this site.
10/29/1999	SUPPL-10	Labeling		Label is not available on this site.
10/29/1999	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
05/19/1999	SUPPL-8	Labeling		Label is not available on this site.
02/19/1999	SUPPL-7	Labeling		Label is not available on this site.
08/31/1998	SUPPL-6	Labeling		Label is not available on this site.
11/26/1997	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
11/26/1997	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/04/1992	SUPPL-3	Labeling		Label is not available on this site.
07/02/1991	SUPPL-2	Labeling		Label is not available on this site.
08/01/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 072423

MEGESTROL ACETATE

TABLET;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEGESTROL ACETATE	MEGESTROL ACETATE	40MG	TABLET;ORAL	Prescription	No	AB	074621	BARR
MEGESTROL ACETATE	MEGESTROL ACETATE	40MG	TABLET;ORAL	Prescription	No	AB	072423	STRIDES PHARMA INTL