FDA.reportPublic FDA data

Application 074728

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUPROLIDE ACETATELEUPROLIDE ACETATEINJECTABLE;INJECTION1MG/0.2MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-7400Leuprolide AcetateLeuprolide AcetateEon Labs, Inc.ANDACurrent
0781-4003Leuprolide AcetateLeuprolide AcetateSandoz IncANDACurrent
0781-4003Leuprolide AcetateLeuprolide AcetateSandoz IncANDACurrent
0781-4003Leuprolide AcetateLeuprolide AcetateSandoz IncANDACurrent
63629-8821Leuprolide AcetateLeuprolide AcetateBryant Ranch PrepackANDACurrent
63629-8821Leuprolide AcetateLeuprolide AcetateBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39437SUPPL2012-08-02
42865ORIG1999-03-15
30692ORIG1998-08-04