FDA.reportPublic FDA data

Application 091135

Type
ANDA
Sponsor
TRIS PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROMETHORPHAN POLISTIREXDEXTROMETHORPHAN POLISTIREXSUSPENSION, EXTENDED RELEASE;ORALEQ 30MG HYDROBROMIDE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8655Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8725Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8726Childrens Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8753Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8754Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirexGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirexWyeth Consumer Healthcare LLCANDACurrent
0031-8755Robitussin 12 Hour Cough Reliefdextromethorphan polistirexRichmond Division of WyethANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0384good sense cough dmdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0958Good Sense Cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0958Good Sense Cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-0958Good Sense Cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0113-7384basic care cough DMdextromethorphan polistirexL. Perrigo CompanyANDACurrent
0363-0384Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0384Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0384Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0494Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0494Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0494Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0899childrens cough dmDextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0899childrens cough dmDextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0899childrens cough dmDextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0958Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0363-0958Cough DMdextromethorphan polistirexWalgreen CompanyANDACurrent
0904-6312cough dmdextromethorphan polistirexMajor PharmaceuticalsANDACurrent
0904-6312cough dmdextromethorphan polistirexMajor PharmaceuticalsANDACurrent
0904-6312cough dmdextromethorphan polistirexMajor PharmaceuticalsANDACurrent
11673-114up and up 12 hour cough reliefdextromethorphan polistirexTarget CorporationANDACurrent
11673-114up and up 12 hour cough reliefdextromethorphan polistirexTarget CorporationANDACurrent
11673-114up and up 12 hour cough reliefdextromethorphan polistirexTarget CorporationANDACurrent
11822-0384Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0384Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0384Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0494Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0494Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0494Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0958Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0958Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
11822-0958Cough DMdextromethorphan polistirexRite Aid CorporationANDACurrent
17856-6312cough dmdextromethorphan polistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-6312cough dmdextromethorphan polistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-6312cough dmdextromethorphan polistirexATLANTIC BIOLOGICALS CORP.ANDACurrent
21130-012signature care 12 hour cough reliefdextromethorphan polistirexSafewayANDACurrent
21130-012signature care 12 hour cough reliefdextromethorphan polistirexSafewayANDACurrent
21130-012signature care 12 hour cough reliefdextromethorphan polistirexSafewayANDACurrent
21130-520Signature Care Cough Reliefdextromethorphan polistirexSafewayANDACurrent
21130-890signature care childrens 12 hour cough reliefDextromethorphan polistirexSafewayANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-384Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-494cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-793childrens cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-793childrens cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-793childrens cough dmdextromethorphan polistirexKroger CompanyANDACurrent
30142-958Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
30142-958Cough DMdextromethorphan polistirexKroger CompanyANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-494TopCare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent
36800-552Topcare Cough DMdextromethorphan polistirexTopco Associates LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48434ORIG2017-05-17
9320ORIG2012-05-30