FDA.reportPublic FDA data

Application 017808

Type
NDA
Sponsor
MYLAN IRELAND LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MIACALCINCALCITONIN SALMONINJECTABLE;INJECTION100 IU/MLYesNo
002MIACALCINCALCITONIN SALMONINJECTABLE;INJECTION200 IU/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-675Miacalcincalcitonin salmonMylan Institutional LLCNDACurrent
67457-675Miacalcincalcitonin salmonMylan Institutional LLCNDACurrent
67457-675Miacalcincalcitonin salmonMylan Institutional LLCNDACurrent
72078-038Miacalcincalcitonin salmonMylan Institutional LLCNDACurrent
72078-038Miacalcincalcitonin salmonMylan Institutional LLCNDACurrent
72078-039Miacalcincalcitonin salmonMylan Institutional LLCNDACurrent
72078-039Miacalcincalcitonin salmonMylan Institutional LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49752SUPPL2017-09-15
49718SUPPL2017-09-12
11066SUPPL2015-02-03
708SUPPL2015-02-03
11065SUPPL2014-03-13
707SUPPL2014-03-13
44014ORIG2014-03-12
13903SUPPL2012-04-23
11064SUPPL2012-04-20
33349SUPPL2009-12-10
706SUPPL2003-06-08
40760SUPPL1997-07-14