Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072423
Company: PAR PHARM
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
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.

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

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