FDA.reportPublic FDA data

Application 076050

Type
ANDA
Sponsor
PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATETABLET, EXTENDED RELEASE;ORAL5MG;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-2007Allergy and Congestion Reliefloratadine, Pseudoephedrine sulfateL. Perrigo CompanyANDACurrent
0113-2007Allergy and Congestion Reliefloratadine, Pseudoephedrine sulfateL. Perrigo CompanyANDACurrent
0113-2007Allergy and Congestion Reliefloratadine, Pseudoephedrine sulfateL. Perrigo CompanyANDACurrent
0113-7777perrigo allergy dloratadine, Pseudoephedrine sulfateL. Perrigo CompanyANDACurrent
0363-0617Wal itin DLoratadine, PseudoephedrineWalgreen CompanyANDACurrent
0363-0617Wal itin DLoratadine, PseudoephedrineWalgreen CompanyANDACurrent
0363-113312 hour allergy and congestionloratadine, Pseudoephedrine sulfateWalgreen CompanyANDACurrent
0363-113312 hour allergy and congestionloratadine, Pseudoephedrine sulfateWalgreen CompanyANDACurrent
0363-113312 hour allergy and congestionloratadine, Pseudoephedrine sulfateWalgreen CompanyANDACurrent
0363-7023allergy relief d 12loratadine, Pseudoephedrine sulfateWalgreen CompanyANDACurrent
0573-2660ALAVERT ALLERGY SINUS D-12loratadine, pseudoephedrine sulfateWyeth Consumer Healthcare LLCANDACurrent
0573-2660ALAVERT ALLERGY SINUS D-12loratadine, pseudoephedrine sulfateGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0573-2660ALAVERT ALLERGY SINUS D-12loratadine, pseudoephedrine sulfateWyeth Consumer Healthcare LLCANDACurrent
11822-0013Allergy and Congestion ReliefLoratadine, PseudoephedrineRite Aid CorporationANDACurrent
11822-1019allergy and congestion reliefloratadine, Pseudoephedrine sulfateRite Aid CorporationANDACurrent
11822-1019allergy and congestion reliefloratadine, Pseudoephedrine sulfateRite Aid CorporationANDACurrent
11822-1019allergy and congestion reliefloratadine, Pseudoephedrine sulfateRite Aid CorporationANDACurrent
11822-1055Allergy Relief Dloratadine, Pseudoephedrine sulfateRite Aid CorporationANDACurrent
11822-1055Allergy Relief Dloratadine, Pseudoephedrine sulfateRite Aid CorporationANDACurrent
21130-007Signature Care Allergy and Congestion ReliefLoratadine, PseudoephedrineSafewayANDACurrent
21130-007Signature Care Allergy and Congestion ReliefLoratadine, PseudoephedrineSafewayANDACurrent
21130-007Signature Care Allergy and Congestion ReliefLoratadine, PseudoephedrineSafewayANDACurrent
21130-482signature care allergy and congestion reliefloratadine, Pseudoephedrine sulfateSafewayANDACurrent
21130-482signature care allergy and congestion reliefloratadine, Pseudoephedrine sulfateSafewayANDACurrent
21130-482signature care allergy and congestion reliefloratadine, Pseudoephedrine sulfateSafewayANDACurrent
21130-482signature care allergy and congestion reliefloratadine, Pseudoephedrine sulfateSafewayANDACurrent
30142-013Allergy and congestion reliefLoratadine, PseudoephedrineKroger CompanyANDACurrent
30142-786allergy and congestion reliefloratadine, Pseudoephedrine sulfateKroger CompanyANDACurrent
30142-786allergy and congestion reliefloratadine, Pseudoephedrine sulfateKroger CompanyANDACurrent
30142-786allergy and congestion reliefloratadine, Pseudoephedrine sulfateKroger CompanyANDACurrent
36800-611topcare allergy and congestion reliefloratadine, pseudoephedrine sulfateTopco Associates LLCANDACurrent
36800-611topcare allergy and congestion reliefloratadine, pseudoephedrine sulfateTopco Associates LLCANDACurrent
36800-611topcare allergy and congestion reliefloratadine, pseudoephedrine sulfateTopco Associates LLCANDACurrent
36800-611topcare allergy and congestion reliefloratadine, pseudoephedrine sulfateTopco Associates LLCANDACurrent
37012-013Allergy Relief DLoratadine, PseudoephedrineShopko Stores Operating Co., LLCANDACurrent
41163-013equaline allergy and congestion reliefLoratadine, PseudoephedrineSupervalu IncANDACurrent
41163-861equaline allergy and congestion reliefloratadine, Pseudoephedrine sulfateSupervalu IncANDACurrent
41250-444Allergy Relief DLoratadine, PseudoephedrineMeijer Distribution IncANDACurrent
41250-954allergy relief dloratadine, Pseudoephedrine sulfateMeijer Distribution IncANDACurrent
41250-954allergy relief dloratadine, Pseudoephedrine sulfateMeijer Distribution IncANDACurrent
41250-954allergy relief dloratadine, Pseudoephedrine sulfateMeijer Distribution IncANDACurrent
41520-013CareOne Allergy and congestion reliefLoratadine, PseudoephedrineAmerican Sales CompanyANDACurrent
41520-013CareOne Allergy and congestion reliefLoratadine, PseudoephedrineAmerican Sales CompanyANDACurrent
41520-013CareOne Allergy and congestion reliefLoratadine, PseudoephedrineAmerican Sales CompanyANDACurrent
41520-918careone allergy and congestion reliefloratadine, Pseudoephedrine sulfateAmerican Sales CompanyANDACurrent
41520-918careone allergy and congestion reliefloratadine, Pseudoephedrine sulfateAmerican Sales CompanyANDACurrent
41520-918careone allergy and congestion reliefloratadine, Pseudoephedrine sulfateAmerican Sales CompanyANDACurrent
45802-106Loratadine DLoratadine, PseudoephedrinePerrigo New York IncANDACurrent
45802-122loratadine Dloratadine, Pseudoephedrine sulfatePerrigo New York IncANDACurrent
45802-122loratadine Dloratadine, Pseudoephedrine sulfatePerrigo New York IncANDACurrent
45802-122loratadine Dloratadine, Pseudoephedrine sulfatePadagis Israel Pharmaceuticals LtdANDACurrent
45802-122loratadine Dloratadine, Pseudoephedrine sulfatePerrigo New York IncANDACurrent
46122-109good neighbor pharmacy loratadine dLoratadine, PseudoephedrineAmerisource BergenANDACurrent
46122-455good neighbor pharmacy loratadine dloratadine, Pseudoephedrine sulfateAmerisource BergenANDACurrent
46122-455good neighbor pharmacy loratadine dloratadine, Pseudoephedrine sulfateAmerisource BergenANDACurrent
46122-455good neighbor pharmacy loratadine dloratadine, Pseudoephedrine sulfateAmerisource BergenANDACurrent
49035-643equate allergy and congestion reliefloratadine, pseudoephedrine sulfateWal-Mart Stores IncANDACurrent
49035-643equate allergy and congestion reliefloratadine, pseudoephedrine sulfateWal-Mart Stores IncANDACurrent
49348-183sunmark loratadine dLoratadine, PseudoephedrineMcKessonANDACurrent
49738-013Smart Sense allergy and congestion reliefLoratadine, PseudoephedrineKmart CorporationANDACurrent
49738-118smart sense allergy and congestion relief dLoratadine, PseudoephedrineKmart CorporationANDACurrent
56062-013allergy relief dLoratadine, PseudoephedrinePublix Super Markets IncANDACurrent
56062-013allergy relief dLoratadine, PseudoephedrinePublix Super Markets IncANDACurrent
56062-555allergy relief dloratadine, Pseudoephedrine sulfatePublix Super Markets IncANDACurrent
56062-555allergy relief dloratadine, Pseudoephedrine sulfatePublix Super Markets IncANDACurrent
56062-555allergy relief dloratadine, Pseudoephedrine sulfatePublix Super Markets IncANDACurrent
59779-013Allergy Relief d 12Loratadine, PseudoephedrineCVS PharmacyANDACurrent
59779-013Allergy Relief d 12Loratadine, PseudoephedrineCVS PharmacyANDACurrent
62011-0354health mart allergy and congestionloratadine, Pseudoephedrine sulfateMcKessonANDACurrent
62011-0354health mart allergy and congestionloratadine, Pseudoephedrine sulfateMcKessonANDACurrent
62011-0354health mart allergy and congestionloratadine, Pseudoephedrine sulfateStrategic Sourcing Services LLCANDACurrent
62011-0354health mart allergy and congestionloratadine, Pseudoephedrine sulfateStrategic Sourcing Services LLCANDACurrent
63629-4790Loratadine DLoratadine, PseudoephedrineBryant Ranch PrepackANDACurrent
63981-013Kirkland Signature AllerClear D 12 hrLoratadine, PseudoephedrineCostco Wholesale CompanyANDACurrent
63981-013Kirkland Signature AllerClear D 12 hrLoratadine, PseudoephedrineCostco Wholesale CompanyANDACurrent
63981-723kirkland signature allerclear d 12 hrloratadine, Pseudoephedrine sulfateCostco Wholesale CompanyANDACurrent
63981-723kirkland signature allerclear d 12 hrloratadine, Pseudoephedrine sulfateCostco Wholesale CompanyANDACurrent
63981-723kirkland signature allerclear d 12 hrloratadine, Pseudoephedrine sulfateCostco Wholesale CompanyANDACurrent
69256-013Harris Teeter Allergy and Congestion ReliefLoratadine, PseudoephedrineHarris Teeter, LLCANDACurrent
69256-257Harris Teeter Allergy and Congestion Reliefloratadine, Pseudoephedrine sulfateHarris Teeter, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22531ORIG2012-03-28
31065ORIG2004-06-08