FDA.reportPublic FDA data

Application 076518

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDENAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL220MG;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-2417sinus and cold dNaproxen sodium, Pseudoephedrine HClL. Perrigo CompanyANDACurrent
0113-2417sinus and cold dNaproxen sodium, Pseudoephedrine HClL. Perrigo CompanyANDACurrent
0280-6045Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6045Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6045Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6045Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6045Aleve-D Sinus and Headachenaproxen sodium, pseudoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6090Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6090Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6090Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6090Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0280-6090Aleve-D Sinus and Coldnaproxen sodium, pseudeoephedrine hydrochlorideBayer HealthCare LLC.ANDACurrent
0363-0650All Day Sinus and Cold DNaproxen sodium, Pseudoephedrine HClWalgreen CompanyANDACurrent
0363-0650All Day Sinus and Cold DNaproxen sodium, Pseudoephedrine HClWalgreen CompanyANDACurrent
11673-417Up and Up Sinus and Cold DNaproxen sodium, Pseudoephedrine HClTarget CorporationANDACurrent
11673-417Up and Up Sinus and Cold DNaproxen sodium, Pseudoephedrine HClTarget CorporationANDACurrent
36800-417Topcare Sinus and Cold DNaproxen sodium, Pseudoephedrine HClTopco Associates LLCANDACurrent
36800-417Topcare Sinus and Cold DNaproxen sodium, Pseudoephedrine HClTopco Associates LLCANDACurrent
36800-417Topcare Sinus and Cold DNaproxen sodium, Pseudoephedrine HClTopco Associates LLCANDACurrent
37000-921Vicks Sinex DAcetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan HydrobromideThe Procter & Gamble Manufacturing CompanyANDACurrent
37000-921Vicks Sinex DAcetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan HydrobromideThe Procter & Gamble Manufacturing CompanyANDACurrent
41250-417Sinus and Cold DNaproxen sodium, Pseudoephedrine HClMeijer Distribution IncANDACurrent
41250-417Sinus and Cold DNaproxen sodium, Pseudoephedrine HClMeijer Distribution IncANDACurrent
46122-197Good Neighbor Pharmacy Sinus and Cold DNaproxen sodium, Pseudoephedrine HClAmerisource BergenANDACurrent
49035-792equate sinus and cold dnaproxen sodium, pseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49035-792equate sinus and cold dnaproxen sodium, pseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49035-792equate sinus and cold dnaproxen sodium, pseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49348-393Sunmark Sinus and Cold DNaproxen sodium, Pseudoephedrine HClStrategic Sourcing Services LLCANDACurrent
49348-393Sunmark Sinus and Cold DNaproxen sodium, Pseudoephedrine HClMcKessonANDACurrent
49348-393Sunmark Sinus and Cold DNaproxen sodium, Pseudoephedrine HClStrategic Sourcing Services LLCANDACurrent
49348-393Sunmark Sinus and Cold DNaproxen sodium, Pseudoephedrine HClStrategic Sourcing Services LLCANDACurrent
50580-434Sudafed Sinus 12 Hour Pressure plus PainNaproxen sodium and Pseudoephedrine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-434Sudafed Sinus 12 Hour Pressure plus PainNaproxen sodium and Pseudoephedrine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-539SudafedNaproxen sodium and Pseudoephedrine HydrochlorideJohnson & Johnson ConsumeANDACurrent
59779-417Sinus and Cold DNaproxen sodium, Pseudoephedrine HClCVS PharmacyANDACurrent
59779-417Sinus and Cold DNaproxen sodium, Pseudoephedrine HClCVS PharmacyANDACurrent
62011-0204Health Mart Sinus and Cold DNaproxen sodium, Pseudoephedrine HClMcKessonANDACurrent
62011-0204Health Mart Sinus and Cold DNaproxen sodium, Pseudoephedrine HClStrategic Sourcing Services LLCANDACurrent
62011-0204Health Mart Sinus and Cold DNaproxen sodium, Pseudoephedrine HClStrategic Sourcing Services LLCANDACurrent
70000-0281Leader Sinus and Cold DNaproxen sodium, Pseudoephedrine HClCardinal HealthANDACurrent
70000-0281Leader Sinus and Cold DNaproxen sodium, Pseudoephedrine HClCardinal HealthANDACurrent
70000-0605Leader All Day Sinus and Cold DNaproxen sodium, Pseudoephedrine HClCardinal Health 110, LLC. dba LeaderANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31135ORIG2004-03-19