FDA.report

Application 021778

Type
NDA
Sponsor
ENDO PHARMS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MEGACE ESMEGESTROL ACETATESUSPENSION;ORAL125MG/MLYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0949Megace ESmegesterol acetateAtlantic Biologicals CorpsNDACurrent
49884-230Megestrol AcetateMegestrol AcetatePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-230Megestrol AcetateMegestrol AcetatePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-230Megestrol AcetateMegestrol AcetatePar Pharmaceutical, Inc.NDA AUTHORIZED GENERICCurrent
49884-949Megace ESmegesterol acetatePar Pharmaceutical, IncNDACurrent
63481-160Megace ESmegesterol acetateEndo Pharmaceuticals Inc.NDACurrent
63481-160Megace ESmegesterol acetateEndo Pharmaceuticals, Inc.NDACurrent
63481-160Megace ESmegesterol acetateEndo Pharmaceuticals, Inc.NDACurrent
63629-2221Megestrol AcetateMegestrol AcetateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-2221Megestrol AcetateMegestrol AcetateBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
56922SUPPL2018-12-21
56907SUPPL2018-12-20
28582SUPPL2014-09-23
37631SUPPL2014-09-22
16357SUPPL2013-05-21
6170SUPPL2013-05-16
37630SUPPL2010-07-30
6169SUPPL2010-07-28
28581SUPPL2008-08-19
21816ORIG2007-07-02
37629SUPPL2007-03-23
28580SUPPL2007-03-23
28579SUPPL2007-03-23
16356SUPPL2007-03-23
28578ORIG2005-07-08
37628ORIG2005-07-07