FDA.report

Application 079113

Type
ANDA
Sponsor
PERRIGO R AND D

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND DIPHENHYDRAMINE CITRATEDIPHENHYDRAMINE CITRATE; IBUPROFENTABLET;ORAL38MG;200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0050good sense ibuprofen pmdiphenhydramine citrate, ibuprofenL. Perrigo CompanyANDACurrent
0113-0050good sense ibuprofen pmdiphenhydramine citrate, ibuprofenL. Perrigo CompanyANDACurrent
0363-0050Ibuprofen PMdiphenhydramine citrate, ibuprofenWalgreen CompanyANDACurrent
0363-0050Ibuprofen PMdiphenhydramine citrate, ibuprofenWalgreen CompanyANDACurrent
0363-0050Ibuprofen PMdiphenhydramine citrate, ibuprofenWalgreen CompanyANDACurrent
0363-0413IbuprofenDiphenhydramine citrate, IbuprofenWalgreen CompanyANDACurrent
10202-0507 Select Ibuprofen PMdiphenhydramine citrate, ibuprofen7-ElevenANDACurrent
10202-0507 Select Ibuprofen PMdiphenhydramine citrate, ibuprofen7-ElevenANDACurrent
11673-050up and up ibuprofen pmdiphenhydramine citrate and ibuprofenTarget CorporationANDACurrent
11673-050up and up ibuprofen pmdiphenhydramine citrate and ibuprofenTarget CorporationANDACurrent
11673-050up and up ibuprofen pmdiphenhydramine citrate and ibuprofenTarget CorporationANDACurrent
11822-0050ibuprofen pmDiphenhydramine Citrate, IbuprofenRite Aid CorporationANDACurrent
11822-0050ibuprofen pmDiphenhydramine Citrate, IbuprofenRite Aid CorporationANDACurrent
21130-030Signature Care Ibuprofen PMDiphenhydramine citrate, IbuprofenSafewayANDACurrent
21130-030Signature Care Ibuprofen PMDiphenhydramine citrate, IbuprofenSafewayANDACurrent
21130-283Signature Care Ibuprofen PMdiphenhydramine citrate, ibuprofenSafewayANDACurrent
21130-283Signature Care Ibuprofen PMdiphenhydramine citrate, ibuprofenSafewayANDACurrent
24385-937Good Neighbor Pharmacy Ibuprofen PMdiphenhydramine citrate, ibuprofenAmerisource BergenANDACurrent
24385-937Good Neighbor Pharmacy Ibuprofen PMdiphenhydramine citrate, ibuprofenAmerisource BergenANDACurrent
24385-937Good Neighbor Pharmacy Ibuprofen PMdiphenhydramine citrate, ibuprofenAmerisource BergenANDACurrent
30142-050ibuprofen pmdiphenhydramine citrate and ibuprofenKroger CompanyANDACurrent
30142-050ibuprofen pmdiphenhydramine citrate and ibuprofenKroger CompanyANDACurrent
30142-050ibuprofen pmdiphenhydramine citrate and ibuprofenKroger CompanyANDACurrent
36800-050Topcare Ibuprofen PMdiphenhydramine citrate and ibuprofenTopco Associates LLCANDACurrent
36800-050Topcare Ibuprofen PMdiphenhydramine citrate and ibuprofenTopco Associates LLCANDACurrent
36800-050Topcare Ibuprofen PMdiphenhydramine citrate and ibuprofenTopco Associates LLCANDACurrent
37012-050Ibuprofen PMdiphenhydramine citrate, ibuprofenShopko Stores Operating Co., LLCANDACurrent
37012-050Ibuprofen PMdiphenhydramine citrate, ibuprofenShopko Stores Operating Co., LLCANDACurrent
37205-360Leader ibuprofen pmdiphenhydramine citrate, ibuprofenCardinal HealthANDACurrent
37808-050rx act ibuprofen pmdiphenhydramine citrate, ibuprofenH E BANDACurrent
37808-050rx act ibuprofen pmdiphenhydramine citrate, ibuprofenH E BANDACurrent
37808-703ibuprofen pmdiphenhydramine citrate, ibuprofenH E BANDACurrent
37808-703ibuprofen pmdiphenhydramine citrate, ibuprofenH E BANDACurrent
41163-050equaline ibuprofen pmdiphenhydramine citrate, ibuprofenSupervalu IncANDACurrent
41163-050equaline ibuprofen pmdiphenhydramine citrate, ibuprofenSupervalu IncANDACurrent
41163-561equaline ibuprofen pmDiphenhydramine citrate, IbuprofenSupervalu IncANDACurrent
41190-050shoprite ibuprofen pmdiphenhydramine citrate, ibuprofenWakefern Food CorporationANDACurrent
41190-050shoprite ibuprofen pmdiphenhydramine citrate, ibuprofenWakefern Food CorporationANDACurrent
41250-050Ibuprofen PMdiphenhydramine citrate, ibuprofenMeijer Distribution IncANDACurrent
41250-413ibuprofen pmDiphenhydramine citrate, IbuprofenMeijer Distribution IncANDACurrent
41250-413ibuprofen pmDiphenhydramine citrate, IbuprofenMeijer Distribution IncANDACurrent
41520-050Care One Ibuprofen PMdiphenhydramine citrate and ibuprofenAmerican Sales CompanyANDACurrent
41520-050Care One Ibuprofen PMdiphenhydramine citrate and ibuprofenAmerican Sales CompanyANDACurrent
41520-413careone ibuprofen pmDiphenhydramine citrate, IbuprofenAmerican Sales CompanyANDACurrent
42507-050ibuprofen pmdiphenhydramine citrate, ibuprofenHyVee IncANDACurrent
46122-145good neighbor pharmacy ibuprofen pmDiphenhydramine citrate, IbuprofenAmerisource BergenANDACurrent
46122-708good neighbor pharmacy ibuprofen pmdiphenhydramine citrate, ibuprofenAmerisource BergenANDACurrent
49035-699equate ibuprofen pmdiphenhydramine citrate, ibuprofenWal-Mart Stores IncANDACurrent
49035-699equate ibuprofen pmdiphenhydramine citrate, ibuprofenWal-Mart Stores IncANDACurrent
49348-873sunmark ibuprofen pmdiphenhydramine citrate and ibuprofenStrategic Sourcing Services LLCANDACurrent
49348-873sunmark ibuprofen pmdiphenhydramine citrate and ibuprofenMcKessonANDACurrent
49348-873sunmark ibuprofen pmdiphenhydramine citrate and ibuprofenStrategic Sourcing Services LLCANDACurrent
49738-191smart sense ibuprofen pmdiphenhydramine citrate, ibuprofenKmart CorporationANDACurrent
49738-191smart sense ibuprofen pmdiphenhydramine citrate, ibuprofenKmart CorporationANDACurrent
50580-563MotrinIbuprofen and Diphenhydramine CitrateJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-563MotrinIbuprofen and Diphenhydramine CitrateJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
50580-563MotrinIbuprofen and Diphenhydramine CitrateJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionANDACurrent
55301-050Exchange Select Ibuprofen PMdiphenhydramine citrate, ibuprofenArmy & Air Force Exchange ServiceANDACurrent
55301-050Exchange Select Ibuprofen PMdiphenhydramine citrate, ibuprofenArmy & Air Force Exchange ServiceANDACurrent
55316-050healthy accents ibuprofen pmdiphenhydramine citrate, ibuprofenDZA Brands LLCANDACurrent
55319-050family wellness ibuprofen pmdiphenhydramine citrate, ibuprofenFamily Dollar Services IncANDACurrent
55319-050ibuprofen pmdiphenhydramine citrate, ibuprofenFamily Dollar Services IncANDACurrent
55319-050family wellness ibuprofen pmdiphenhydramine citrate, ibuprofenFamily Dollar Services IncANDACurrent
55910-050dg health Ibuprofen pmdiphenhydramine citrate and ibuprofenDolgencorp IncANDACurrent
55910-050dg health Ibuprofen pmdiphenhydramine citrate and ibuprofenDolgencorp IncANDACurrent
55910-050dg health Ibuprofen pmdiphenhydramine citrate and ibuprofenDolgencorp IncANDACurrent
55910-050dg health Ibuprofen pmdiphenhydramine citrate and ibuprofenDolgencorp IncANDACurrent
55910-413DG Health IbuprofenDiphenhydramine citrate, IbuprofenDolgencorp, LLCANDACurrent
55910-413DG Health IbuprofenDiphenhydramine citrate, IbuprofenDolgencorp, LLCANDACurrent
56062-050ibuprofen pmdiphenhydramine citrate, ibuprofenPublix Super Markets IncANDACurrent
59779-050ibuprofen pmdiphenhydramine citrate and ibuprofenCVS PharmacyANDACurrent
59779-050ibuprofen pmdiphenhydramine citrate and ibuprofenCVS PharmacyANDACurrent
59779-413ibuprofen pmDiphenhydramine citrate, IbuprofenCVS PharmacyANDACurrent
62011-0335Health Mart ibuprofen PMdiphenhydramine citrate, ibuprofenStrategic Sourcing Services LLCANDACurrent
62011-0335Health Mart ibuprofen PMdiphenhydramine citrate, ibuprofenStrategic Sourcing Services LLCANDACurrent
62011-0335Health Mart ibuprofen PMdiphenhydramine citrate, ibuprofenMckessonANDACurrent
68391-050berkley and jensen ibuprofen pmdiphenhydramine citrate, ibuprofenBJWCANDACurrent
68391-050berkley and jensen ibuprofen pmdiphenhydramine citrate, ibuprofenBJWCANDACurrent
69256-050Harris Teeter Ibuprofen PMdiphenhydramine citrate, ibuprofenHarris Teeter, LLCANDACurrent
69256-050Harris Teeter Ibuprofen PMdiphenhydramine citrate, ibuprofenHarris Teeter, LLCANDACurrent

Documents

DocumentSubmission typeDate
22634ORIG2012-03-28