FDA.reportPublic FDA data

Application 021983

Type
NDA
Sponsor
MERIDIAN MEDCL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUODOTEATROPINE; PRALIDOXIME CHLORIDEINJECTABLE;INTRAMUSCULAR2.1MG/0.7ML;600MG/2MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies LLCNDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical Technologies, Inc.NDACurrent
11704-620DuoDoteatropine and pralidoxime chlorideMeridian Medical TechnologiesNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71102SUPPL2022-05-19
71089SUPPL2022-05-18
50013SUPPL2017-10-11
49997SUPPL2017-10-10
21894ORIG2009-07-15
6583ORIG2006-10-02
51751SUPPL1900-01-01
51750SUPPL1900-01-01
51749SUPPL1900-01-01