Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074621
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGESTROL ACETATE MEGESTROL ACETATE 40MG TABLET;ORAL Prescription AB No No
MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/1995 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
07/29/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

03/18/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

03/12/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-17 Labeling

Label is not available on this site.

01/31/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/2002 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/05/2000 SUPPL-14 Labeling

Label is not available on this site.

12/21/1999 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/25/1998 SUPPL-11 Labeling

Label is not available on this site.

12/01/1998 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/17/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/24/1998 SUPPL-8 Labeling

Label is not available on this site.

03/17/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/08/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-2 Labeling

Label is not available on this site.

08/16/1996 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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 PAR PHARM
MEGESTROL ACETATE MEGESTROL ACETATE 40MG TABLET;ORAL Prescription No AB 074458 WEST-WARD PHARMS INT

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET;ORAL Prescription No AB 074621 BARR
MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET;ORAL Prescription No AB 072422 PAR PHARM
MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET;ORAL Prescription No AB 074458 WEST-WARD PHARMS INT

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