FDA.reportPublic FDA data

Application 075153

Type
ANDA
Sponsor
L PERRIGO CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PSEUDOEPHEDRINE HYDROCHLORIDEPSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0054Good Sense SuphedrinePseudoephedrine HydrochlorideL. Perrigo CompanyANDACurrent
0113-0054Good Sense SuphedrinePseudoephedrine HydrochlorideL. Perrigo CompanyANDACurrent
0113-2017sinus 12 hourPseudoephedrine HClL. Perrigo CompanyANDACurrent
0113-2017sinus 12 hourPseudoephedrine HClL. Perrigo CompanyANDACurrent
0113-2017sinus 12 hourPseudoephedrine HClL. Perrigo CompanyANDACurrent
0113-205412 hour decongestantPseudoephedrine HydrochlorideL. Perrigo CompanyANDACurrent
0363-0061walphed dPseudoephedrine HClWalgreen CompanyANDACurrent
0363-0061walphed dPseudoephedrine HClWalgreen CompanyANDACurrent
0363-3301Nasal Decongestant DPseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0904-6754SudoGest 12 HourPseudoephedrine HClMajor PharmaceuticalsANDACurrent
0904-6754SudoGest 12 HourPseudoephedrine HClMajor PharmaceuticalsANDACurrent
0904-6754SudoGest 12 HourPseudoephedrine HClMajor PharmaceuticalsANDACurrent
11673-112up and up sinus 12 hourPseudoephedrine HClTarget CorporationANDACurrent
11822-0650sinus pressure and congestion reliefPseudoephedrine HClRite Aid CorporationANDACurrent
11822-0650sinus pressure and congestion reliefPseudoephedrine HClRite Aid CorporationANDACurrent
11822-0650sinus pressure and congestion reliefPseudoephedrine HClRite Aid CorporationANDACurrent
24385-054good neighbor pharmacy nasal decongestantPseudoephedrine HydrochlorideAmerisource BergenANDACurrent
24385-054good neighbor pharmacy nasal decongestantPseudoephedrine HydrochlorideAmerisource BergenANDACurrent
30142-05412 hour decongestantPseudoephedrine HydrochlorideKroger CompanyANDACurrent
30142-05412 hour decongestantPseudoephedrine HydrochlorideKroger CompanyANDACurrent
30142-559sinusPseudoephedrine HClKroger CompanyANDACurrent
36800-054topcare 12 hour decongestantPseudoephedrine HydrochlorideTopco Associates LLCANDACurrent
36800-054topcare 12 hour decongestantPseudoephedrine HydrochlorideTopco Associates LLCANDACurrent
36800-054topcare 12 hour decongestantPseudoephedrine HydrochlorideTopco Associates LLCANDACurrent
37012-054Nasal DecongestantPseudoephedrine HClShopko Stores Operating Co., LLCANDACurrent
37012-054Nasal DecongestantPseudoephedrine HClShopko Stores Operating Co., LLCANDACurrent
37205-446Leader 12 Hour Nasal DecongestantPseudoephedrine HydrochlorideCardinal HealthANDACurrent
41163-054Equaline 12 Hour DecongestantPseudoephedrine HydrochlorideSupervalu IncANDACurrent
41163-054Equaline 12 Hour DecongestantPseudoephedrine HydrochlorideSupervalu IncANDACurrent
41190-054ShopRite Nasal DecongestantPseudoephedrine HClWakefern Food CorporationANDACurrent
41190-054ShopRite Nasal DecongestantPseudoephedrine HClWakefern Food CorporationANDACurrent
41190-054ShopRite Nasal DecongestantPseudoephedrine HClWakefern Food CorporationANDACurrent
41250-05412 hour decongestantPseudoephedrine HydrochlorideMeijer Distribution IncANDACurrent
41250-05412 hour decongestantPseudoephedrine HydrochlorideMeijer Distribution IncANDACurrent
41250-809nasal decongestantpseudoephedrine hydrochlorideMeijer Distribution IncANDACurrent
41250-809nasal decongestantpseudoephedrine hydrochlorideMeijer Distribution IncANDACurrent
41520-054careone suphedrine 12 hour reliefPseudoephedrine HydrochlorideAmerican Sales CompanyANDACurrent
41520-429CareOne Nasal and Sinus DecongestantPseudoephedrine HClAmerican Sales CompanyANDACurrent
41520-429CareOne Nasal and Sinus DecongestantPseudoephedrine HClAmerican Sales CompanyANDACurrent
42254-359nasal decongestantPseudoephedrine HydrochlorideRebel Distributors CorpANDACurrent
42507-054nasal decongestantPseudoephedrine HydrochlorideHyVee IncANDACurrent
45802-107pseudoephedrine hydrochloridePseudoephedrine HClPadagis Israel Pharmaceuticals LtdANDACurrent
45802-107pseudoephedrine hydrochloridePseudoephedrine HClPerrigo New York IncANDACurrent
45802-107pseudoephedrine hydrochloridePseudoephedrine HClPerrigo New York IncANDACurrent
49035-508equate sinus 12 hourpseudoephedrine hydrochlorideWal-Mart Stores IncANDACurrent
49348-361Sunmark SinusPseudoephedrine HydrochlorideMcKessonANDACurrent
49738-009smart sense sinus 12 hourPseudoephedrine HClKmart CorporationANDACurrent
49738-054smart sense 12 hour decongestantPseudoephedrine HydrochlorideKmart CorporationANDACurrent
50090-3287SUDAFED 12 HOURPseudoephedrine HydrochlorideA-S Medication SolutionsANDACurrent
50090-3287SUDAFED 12 HOURPseudoephedrine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4629Sudafed Sinus Congestion 12 HourPseudoephedrine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4629Sudafed Sinus Congestion 12 HourPseudoephedrine HydrochlorideA-S Medication SolutionsANDACurrent
50580-242Sudafed Sinus Congestion 12 HourPseudoephedrine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-242Sudafed Sinus Congestion 12 HourPseudoephedrine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-342SUDAFED 12 HOURPseudoephedrine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
55316-054Healthy Accents 12 Hour Nasal DecongestantPseudoephedrine HydrochlorideDZA Brands LLCANDACurrent
59779-70312 Hour Nasal DecongestantPseudoephedrine HydrochlorideCVS PharmacyANDACurrent
59779-70312 Hour Nasal DecongestantPseudoephedrine HydrochlorideCVS PharmacyANDACurrent
62011-0087Health Mart nasal decongestantPseudoephedrine HydrochlorideMcKessonANDACurrent
69256-054Harris Teeter Sinus 12 HourPseudoephedrine HClHarris Teeter, LLCANDACurrent
69256-054Harris Teeter Sinus 12 HourPseudoephedrine HClHarris Teeter, LLCANDACurrent
69256-054Harris Teeter Sinus 12 HourPseudoephedrine HClHarris Teeter, LLCANDACurrent
70000-0475leader 12 hour nasal decongestantPseudoephedrine HydrochlorideCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0475leader 12 hour nasal decongestantPseudoephedrine HydrochlorideCardinal HealthANDACurrent
70000-0475leader 12 hour nasal decongestantPseudoephedrine HydrochlorideCardinal HealthANDACurrent
70518-1618pseudoephedrine hydrochloridePseudoephedrine HClREMEDYREPACK INC.ANDACurrent
70518-1618pseudoephedrine hydrochloridePseudoephedrine HClREMEDYREPACK INC.ANDACurrent
70518-1618pseudoephedrine hydrochloridePseudoephedrine HClREMEDYREPACK INC.ANDACurrent
70518-1618pseudoephedrine hydrochloridePseudoephedrine HClREMEDYREPACK INC.ANDACurrent
70518-1618pseudoephedrine hydrochloridePseudoephedrine HClREMEDYREPACK INC.ANDACurrent
70518-2654Sudafed Sinus Congestion 12 HourPseudoephedrine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2654Sudafed Sinus Congestion 12 HourPseudoephedrine HydrochlorideREMEDYREPACK INC.ANDACurrent
80159-302Picnic Nasal DecongestantPseudoephedrine HCl30M One, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8540ORIG1999-02-26