Application 202344

Type
NDA
Sponsor
ASCEND THERAPS US

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001BINOSTOALENDRONATE SODIUMTABLET, EFFERVESCENT;ORALEQ 70MG BASEYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0178-0101Binostoalendronate sodiumMission Pharmacal CompanyNDACurrent
17139-400Binostoalendronate sodiumASCEND TherapeuticsNDACurrent
17139-400Binostoalendronate sodiumASCEND Therapeutics U.S., LLCNDACurrent
17139-400Binostoalendronate sodiumASCEND TherapeuticsNDACurrent
17139-400Binostoalendronate sodiumASCEND TherapeuticsNDACurrent
17139-400Binostoalendronate sodiumASCEND TherapeuticsNDACurrent
17139-400Binostoalendronate sodiumASCEND TherapeuticsNDACurrent
17139-400Binostoalendronate sodiumASCEND Therapeutics U.S., LLCNDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
849320SUPPL 222026-02-05Cached in FDA.report object storage
849200SUPPL 222026-02-05Cached in FDA.report object storage
849330SUPPL 222026-02-03Cached in FDA.report object storage
649220SUPPL152020-10-15Cached in FDA.report object storage
649190SUPPL152020-10-14Cached in FDA.report object storage
634640SUPPL132020-06-09Cached in FDA.report object storage
634630SUPPL132020-06-09Cached in FDA.report object storage
562350SUPPL82018-11-01Cached in FDA.report object storage
466500SUPPL112017-01-03Cached in FDA.report object storage
466340SUPPL112017-01-03Cached in FDA.report object storage
322470SUPPL102016-03-24Cached in FDA.report object storage
322460SUPPL82015-04-13Cached in FDA.report object storage
193340SUPPL82015-04-10Cached in FDA.report object storage
193330SUPPL72015-03-03Cached in FDA.report object storage
322450SUPPL72015-02-27Cached in FDA.report object storage
193320SUPPL22013-08-09Cached in FDA.report object storage
448540ORIG12013-04-29Cached in FDA.report object storage
433980ORIG12013-04-29FDA source fallback
401730SUPPL12013-04-23Cached in FDA.report object storage
100340SUPPL12013-04-23Cached in FDA.report object storage
24102Medication GuideORIG12012-08-30FDA source fallback
193310ORIG12012-08-30Cached in FDA.report object storage
322440ORIG12012-03-26Cached in FDA.report object storage