Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075997
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEGESTROL ACETATE MEGESTROL ACETATE 40MG/ML SUSPENSION;ORAL Discontinued None 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
02/15/2002 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075997.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2020 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

10/02/2007 SUPPL-9 Labeling

Label is not available on this site.

05/14/2007 SUPPL-8 Labeling

Label is not available on this site.

06/06/2003 SUPPL-2 Labeling

Label is not available on this site.

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