FDA.report

Application 078539

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo
002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 8MG BASENoNo
003ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 24MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0247Ondansetron HydrochlorideOndansetron HydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0179-0248Ondansetron HydrochlorideOndansetron HydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
10544-575Ondansetron HydrochlorideOndansetron HydrochlorideBlenheim Pharmacal, Inc.ANDACurrent
16714-159OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-159OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-160OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-160OndansetronOndansetronNorthStar Rx LLCANDACurrent
33261-417Ondansetron HydrochlorideOndansetron HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
33261-745Ondansetron HydrochlorideOndansetron HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
42708-044Ondansetron HydrochlorideOndansetron HydrochlorideQPharma IncANDACurrent
42708-044Ondansetron HydrochlorideOndansetron HydrochlorideQPharma IncANDACurrent
42708-044Ondansetron HydrochlorideOndansetron HydrochlorideQPharma IncANDACurrent
42708-059Ondansetron HydrochlorideOndansetron HydrochlorideQPharma IncANDACurrent
42708-059Ondansetron HydrochlorideOndansetron HydrochlorideQPharma IncANDACurrent
42708-059Ondansetron HydrochlorideOndansetron HydrochlorideQPharma IncANDACurrent
43063-792Ondansetron HydrochlorideOndansetron HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-792Ondansetron HydrochlorideOndansetron HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-792Ondansetron HydrochlorideOndansetron HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-792Ondansetron HydrochlorideOndansetron HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-792Ondansetron HydrochlorideOndansetron HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-509Ondansetron HydrochlorideOndansetron Hydrochloridemedsource pharmaceuticalsANDACurrent
50090-3178Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3178Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3178Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3178Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3185Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3185Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3185Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-3185Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-4671Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-4671Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50090-4671Ondansetron HydrochlorideOndansetron HydrochlorideA-S Medication SolutionsANDACurrent
50268-621Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50268-621Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50268-621Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50268-621Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50268-622Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50268-622Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50268-622Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50268-622Ondansetron HydrochlorideOndansetron HydrochlorideAvPAKANDACurrent
50436-0187Ondansetron HydrochlorideOndansetron HydrochlorideUnit Dose ServicesANDACurrent
50436-0187Ondansetron HydrochlorideOndansetron HydrochlorideUnit Dose ServicesANDACurrent
50436-1880Ondansetron HydrochlorideOndansetron HydrochlorideUnit Dose ServicesANDACurrent
50436-1880Ondansetron HydrochlorideOndansetron HydrochlorideUnit Dose ServicesANDACurrent
51655-415Ondansetron HydrochlorideOndansetron HydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-0571Ondansetron HydrochlorideOndansetron HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-0601Ondansetron HydrochlorideOndansetron HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53808-1121Ondansetron HydrochlorideOndansetron HydrochlorideDOH CENTRAL PHARMACYANDACurrent
54348-819OndansetronONDANSETRONPharmPak, Inc.ANDACurrent
54348-819OndansetronONDANSETRONPharmPak, Inc.ANDACurrent
54348-821Ondansetron HydrochlorideOndansetron HydrochloridePharmpak, Inc.ANDACurrent
54348-821Ondansetron HydrochlorideOndansetron HydrochloridePharmpak, Inc.ANDACurrent
55154-8176Ondansetron HydrochlorideOndansetron HydrochlorideCardinal Health 107, LLCANDACurrent
55154-8176Ondansetron HydrochlorideOndansetron HydrochlorideCardinal HealthANDACurrent
55154-8176Ondansetron HydrochlorideOndansetron HydrochlorideCardinal HealthANDACurrent
55700-627Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA QuaANDACurrent
55700-627Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-627Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-627Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-631Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-631Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-631Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-631Ondansetron HydrochlorideOndansetron HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
57237-075Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-075Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-075Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-075Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-075Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-076Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-076Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-076Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-076Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
57237-076Ondansetron HydrochlorideOndansetron HydrochlorideRising Health, LLCANDACurrent
58118-7500Ondansetron HydrochlorideOndansetron HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-7500Ondansetron HydrochlorideOndansetron HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-7500Ondansetron HydrochlorideOndansetron HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
60760-636Ondansetron HydrochlorideOndansetron HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-636Ondansetron HydrochlorideOndansetron HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-636Ondansetron HydrochlorideOndansetron HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent
60760-636Ondansetron HydrochlorideOndansetron HydrochlorideSt. Mary's Medical Park PharmacyANDACurrent