FDA.reportPublic FDA data

Application 017692

Type
BLA
Sponsor
ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGNYLGONADOTROPIN, CHORIONICINJECTABLE;INJECTION10,000 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0052-0315PregnylCHORIOGONADOTROPIN ALFAOrganon USA Inc.BLACurrent
0052-0315PregnylCHORIOGONADOTROPIN ALFAMerck Sharp & Dohme LLCBLACurrent
0052-0315PregnylCHORIOGONADOTROPIN ALFAOrganon USA Inc.NDACurrent
0052-0315PregnylCHORIOGONADOTROPIN ALFAOrganon USA Inc.NDACurrent
50090-5923PregnylCHORIOGONADOTROPIN ALFAA-S Medication SolutionsBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73706SUPPL 2023-03-08
73705SUPPL 2023-03-08
73704SUPPL 2023-03-08
73661SUPPL 2023-03-03
73660SUPPL 2023-03-03
73659SUPPL 2023-03-03
62216APPL2020-03-23
33335SUPPL2020-03-23
33334SUPPL2020-03-23
13881SUPPL2020-03-23
687SUPPL2020-03-23
686SUPPL2020-03-23