Application 205920

Type
NDA
Sponsor
ARMSTRONG PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PRIMATENE MISTEPINEPHRINEAEROSOL, METERED;INHALATION0.125MG/INHYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
17270-553Primatene MistEpinephrine InhalationArmstrong Pharmaceuticals, Inc.NDACurrent
17270-553Primatene MistEpinephrine InhalationArmstrong Pharmaceuticals, Inc.NDACurrent
17270-553Primatene MistEpinephrine InhalationArmstrong Pharmaceuticals, Inc.NDACurrent

Documents

DocumentSubmission typeDate
58930ORIG2019-06-03
56337ORIG2018-11-08
56335ORIG2018-11-08