FDA.reportPublic FDA data

Application 211544

Type
ANDA
Sponsor
GRANULES INDIA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHENACETAMINOPHENTABLET, EXTENDED RELEASE;ORAL650MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9992AcetaminophenAcetaminophenWALGREENSANDACurrent
0363-9992AcetaminophenAcetaminophenWALGREENSANDACurrent
0363-9992AcetaminophenAcetaminophenWALGREENSANDACurrent
0363-9992AcetaminophenAcetaminophenWALGREENSANDACurrent
0363-9993AcetaminophenAcetaminophenWALGREENS CO.ANDACurrent
0363-9993AcetaminophenAcetaminophenWALGREENS CO.ANDACurrent
0363-9993AcetaminophenAcetaminophenWALGREENS CO.ANDACurrent
0363-9993AcetaminophenAcetaminophenWALGREENS CO.ANDACurrent
11822-5019AcetaminophenAcetaminophenRITE AIDANDACurrent
11822-5019AcetaminophenAcetaminophenRITE AIDANDACurrent
11822-5091AcetaminophenAcetaminophenRITE AIDANDACurrent
11822-6019Muscle Pain ReliefAcetaminophenRite Aid CorporationANDACurrent
11822-6019Muscle Pain ReliefAcetaminophenRite Aid CorporationANDACurrent
11822-6304AcetaminophenAcetaminophenRite Aid CorporationANDACurrent
11822-6304AcetaminophenAcetaminophenRite Aid CorporationANDACurrent
11822-6304AcetaminophenAcetaminophenRite Aid CorporationANDACurrent
11822-6304AcetaminophenAcetaminophenRite Aid CorporationANDACurrent
21130-124Arthritis PainAcetaminophenSAFEWAYANDACurrent
21130-124Arthritis PainAcetaminophenSAFEWAYANDACurrent
36800-632Arthritis Pain ReliefAcetaminophenTOPCO ASSOCIATES LLCANDACurrent
37808-120HEBAcetaminophenHEBANDACurrent
41163-203eight hour pain reliefAcetaminophenUNFIANDACurrent
41250-658arthritis pain reliefAcetaminophenMeijerANDACurrent
46122-6298 Hour Arthritis PainAcetaminophenAMERISOURCE BERGENANDACurrent
46122-6298 Hour Arthritis PainAcetaminophenAMERISOURCE BERGENANDACurrent
46122-6298 Hour Arthritis PainAcetaminophenAMERISOURCE BERGENANDACurrent
46122-6308 Hour Pain ReliefAcetaminophenAMERISOURCE BERGENANDACurrent
46122-6308 Hour Pain ReliefAcetaminophenAMERISOURCE BERGENANDACurrent
46122-6308 Hour Pain ReliefAcetaminophenAMERISOURCE BERGENANDACurrent
46122-6308 Hour Pain ReliefAcetaminophenAMERISOURCE BERGENANDACurrent
49035-181AcetaminophenAcetaminophenWAL-MART STORES INCANDACurrent
49035-181AcetaminophenAcetaminophenWAL-MART STORES INCANDACurrent
49035-181AcetaminophenAcetaminophenWAL-MART STORES INCANDACurrent
50594-183AcetaminophenAcetaminophenBIG LOTS STORES, INC.ANDACurrent
50594-183AcetaminophenAcetaminophenBIG LOTS STORES, INC.ANDACurrent
53943-200Arthritis PainAcetaminophenDISCOUNT DRUG MARTANDACurrent
54257-573Acetaminophen Extended-ReleaseACETAMINOPHENMagno-Humphries, Inc.ANDACurrent
54257-573Acetaminophen Extended-ReleaseACETAMINOPHENMagno-Humphries, Inc.ANDACurrent
54257-573Acetaminophen Extended-ReleaseACETAMINOPHENMagno-Humphries, Inc.ANDACurrent
57896-268ACETAMINOPHENACETAMINOPHENGERI-CARE PHARMACEUTICAL CORPANDACurrent
59726-013Arthritis Pain RelieverAcetaminophenP & L Development, LLCANDACurrent
62207-183ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-183ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-183ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-183ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-183ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-183ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-183ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-188ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-188ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-188ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-188ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-188ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-188ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
62207-188ACETAMINOPHENACETAMINOPHENGranules India LimitedANDACurrent
63868-412AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-412AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-413AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-413AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-591AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-591AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-660AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-660AcetaminophenAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63868-6798 Hour Pain ReliefAcetaminophenCHAIN DRUG MARKETING ASSOCIATION INCANDACurrent
63941-3008 Hour Arthritis PainAcetaminophenVALU MERCHANDISERS COMPANYANDACurrent
63941-4018 Hour Pain ReliefAcetaminophenVALU MERCHANDISERS COMPANYANDACurrent
68016-183AcetaminophenAcetaminophenPHARMACY VALUE ALLIANCE, LLCANDACurrent
68016-183AcetaminophenAcetaminophenPHARMACY VALUE ALLIANCE, LLCANDACurrent
68016-303Arthritis Pain ReliefAcetaminophenCHAIN DRUG CONSORTIUMANDACurrent
68196-935AcetaminophenAcetaminophenSAM'S WEST INCANDACurrent
68998-300Arthritis PainAcetaminophenMARC GLASSMAN, INC.ANDACurrent
68998-4018 Hour Arthritis PainAcetaminophenMARC GLASSMAN, INC.ANDACurrent
69842-297AcetaminophenAcetaminophenCVS PHARMACY iNCANDACurrent
69842-297AcetaminophenAcetaminophenCVS PHARMACY iNCANDACurrent
69842-297AcetaminophenAcetaminophenCVS PHARMACY iNCANDACurrent
69842-322AcetaminophenAcetaminophenCVS PHARMACY INCANDACurrent
69848-015AcetaminophenAcetaminophenGranules USA, Inc.ANDACurrent
69848-015AcetaminophenAcetaminophenGranules USA, Inc.ANDACurrent
69848-015AcetaminophenAcetaminophenGranules USA, Inc.ANDACurrent
70010-160ACETAMINOPHENACETAMINOPHENGranules Pharmaceuticals Inc.ANDACurrent