FDA.report

Application 018658

Type
NDA
Sponsor
RB HLTH

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DELSYMDEXTROMETHORPHAN POLISTIREXSUSPENSION, EXTENDED RELEASE;ORALEQ 30MG HYDROBROMIDE/5MLYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0172DelsymDextromethorphanATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0172DelsymDextromethorphanATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0172DelsymDextromethorphanATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0172DelsymDextromethorphanATLANTIC BIOLOGICALS CORP.NDACurrent
17856-0276Delsym (Dextromethorphan)DextromethorphanAtlantic Biologicals CorpsNDACurrent
21695-517DelsymDextromethorphan PolistirexRebel Distributors CorpNDACurrent
21695-518DelsymDextromethorphan PolistirexRebel Distributors CorpNDACurrent
50090-0224DelsymDextromethorphanA-S Medication SolutionsNDACurrent
50090-0224DelsymDextromethorphanA-S Medication SolutionsNDACurrent
50090-0224DelsymDextromethorphanA-S Medication SolutionsNDACurrent
50090-0224DelsymDextromethorphanA-S Medication SolutionsNDACurrent
50090-0224DelsymDextromethorphanA-S Medication SolutionsNDACurrent
63824-171DelsymDextromethorphanRB Health (US) LLCNDACurrent
63824-171DelsymDextromethorphanReckitt Benckiser LLCNDACurrent
63824-171DelsymDextromethorphanRB Health (US) LLCNDACurrent
63824-172DelsymDextromethorphanReckitt Benckiser LLCNDACurrent
63824-173Delsym (Dextromethorphan)DextromethorphanRB Health (US) LLCNDACurrent
63824-173Delsym (Dextromethorphan)DextromethorphanReckitt Benckiser LLCNDACurrent
63824-173Delsym (Dextromethorphan)DextromethorphanRB Health (US) LLCNDACurrent
63824-175DelsymDextromethorphanRB Health (US) LLCNDACurrent
63824-175DelsymDextromethorphanRB Health (US) LLCNDACurrent
63824-175DelsymDextromethorphanReckitt Benckiser LLCNDACurrent
63824-176DelsymDextromethorphanReckitt Benckiser LLCNDACurrent
63824-177Delsym (Dextromethorphan)DextromethorphanRB Health (US) LLCNDACurrent
63824-177Delsym (Dextromethorphan)DextromethorphanRB Health (US) LLCNDACurrent
63824-177Delsym (Dextromethorphan)DextromethorphanReckitt Benckiser LLCNDACurrent
70518-1912DelsymDextromethorphanREMEDYREPACK INC.NDACurrent
70518-1912DelsymDextromethorphanREMEDYREPACK INC.NDACurrent
70518-1912DelsymDextromethorphanREMEDYREPACK INC.NDACurrent

Documents

DocumentSubmission typeDate
77867SUPPL 2024-03-19
77855SUPPL 2024-03-18
64275SUPPL2020-08-13
15077SUPPL2014-08-11
11266SUPPL2014-08-05
1005SUPPL2011-05-19
1004SUPPL2010-11-15
15076SUPPL2010-04-13
15075SUPPL2009-11-12
15074SUPPL2008-12-10
33543SUPPL2007-10-04
1003SUPPL2007-10-04
40816SUPPL2007-04-09
1002SUPPL2005-03-10
1001SUPPL2004-11-16
15073SUPPL2002-01-24