FDA.report

Application 074567

Type
ANDA
Sponsor
OHM LABS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROHM COLD AND SINUSIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET;ORAL200MG;30MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideWALGREEN COMPANYANDACurrent
0363-0423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideWALGREEN COMPANYANDACurrent
0363-0423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideWALGREEN COMPANYANDACurrent
11673-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideTarget CorporationANDACurrent
11822-0084Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideRite-AidANDACurrent
11822-0084Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideRite-AidANDACurrent
21130-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideSafeway Inc.ANDACurrent
30142-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideThe Kroger CompanyANDACurrent
30142-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideThe Kroger CompanyANDACurrent
36800-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideTopco Associates LLCANDACurrent
37808-324Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideHEBANDACurrent
37808-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideHEBANDACurrent
41250-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideMeijer Distribution, IncANDACurrent
46084-091IBUPROFEN COLD AND SINUSIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEA P J Laboratories LimitedANDACurrent
49348-097Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideSunmarkANDACurrent
51660-423Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-423Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-490Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-490Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-493Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
51660-493Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideOhm Laboratories Inc.ANDACurrent
53943-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideDiscount Drug MartANDACurrent
56062-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochloridePublix Super Markets IncANDACurrent
59779-430Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideCVS PharmacyANDACurrent
59779-430Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideCVS PharmacyANDACurrent
62011-0070Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideStrategic Sourcing Services LLCANDACurrent
62011-0070Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideHealth MartANDACurrent
63629-5284Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideBryant Ranch PrepackANDACurrent
63629-5284Ibuprofen and Pseudoephedrine hydrochlorideibuprofen and pseudoephedrine hydrochlorideBryant Ranch PrepackANDACurrent
63868-453Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideChain Drug Marketing Association Inc.ANDACurrent
68016-423Ibuprofen and Pseudoephedrine HydrochlorideIbuprofen and Pseudoephedrine HydrochlorideChain Drug Consortium, LLC.ANDACurrent
68258-8902Good Neighbor Pharmacy Ibuprofen Cold and SinusIbuprofen, Pseudoephedrine HydrochlorideDispensing Solutions, Inc.ANDACurrent
70000-0602IBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDEIBUPROFEN and PSEUDOEPHEDRINE HYDROCHLORIDECARDINAL HEALTH 110, LLC DBA LEADERANDACurrent

Documents

DocumentTitleSubmission typeSubmission no.DateStorage
428540ORIG12005-07-22FDA source fallback
84250ORIG12001-04-17FDA source fallback