Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074458
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET;ORAL Prescription AB No No
MEGESTROL ACETATE MEGESTROL ACETATE 40MG 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
09/29/1995 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
10/02/2007 SUPPL-6 Labeling

Label is not available on this site.

05/30/2007 SUPPL-5 Labeling

Label is not available on this site.

05/20/2003 SUPPL-4 Labeling

Label is not available on this site.

12/12/2001 SUPPL-3 Labeling

Label is not available on this site.

12/03/1998 SUPPL-2 Labeling

Label is not available on this site.

08/24/1998 SUPPL-1 Labeling

Label is not available on this site.

MEGESTROL ACETATE

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 074458 HIKMA
MEGESTROL ACETATE MEGESTROL ACETATE 20MG TABLET;ORAL Prescription No AB 072422 PAR PHARM

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 074458 HIKMA
MEGESTROL ACETATE MEGESTROL ACETATE 40MG TABLET;ORAL Prescription No AB 072423 PAR PHARM

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