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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211544-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8HR Arthritis PainACETAMINOPHENHARRIS TEETERbfee9b3e-0c50-7c10-e053-2995a90af2fe2026-08-05WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
8 HR Arthritis PainACETAMINOPHENDr. Reddy's Laboratories Inc.8e780c23-997c-b960-226e-954037baad4b2026-07-01WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ACETAMINOPHENACETAMINOPHENGranules India Limited00eb3e4b-1507-4c9a-83a5-ef50cb3127532026-06-15WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 62207-188
ndc (product): 62207-183
Arthritis PainACETAMINOPHENGrocery Outlet, Inc.441d0aa0-9a65-98e9-e063-6294a90a5eb22026-05-21WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ACETAMINOPHENACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labsa3217b48-7482-4cc7-8811-ae75fd9d78052026-02-26WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENCVS PHARMACY INCbd8ce39f-ccf8-3976-e053-2a95a90abb1f2025-12-23WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 69842-322
AcetaminophenACETAMINOPHENGranules USA, Inc.96131c7b-bdff-0642-e053-2a95a90a4f322025-12-22WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 69848-015
AcetaminophenACETAMINOPHENWAL-MART STORES INC940936ac-e59f-7489-e053-2a95a90a63642025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 49035-181
AcetaminophenACETAMINOPHENWAL-MART STORES INCe34d07b5-ccbb-cd14-e053-2a95a90a394b2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENMEIJER DISTRIBUTION INCed23c587-7806-1f64-e053-2a95a90aea7f2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENMEIJER, INC.ed25620f-e39b-e30c-e053-2995a90af6212025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a0fb0afe-9c25-d0f6-e053-2995a90adbba2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES,LLC.a56791ec-0037-51a3-e053-2995a90af7612025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENWALGREENS8f8d43d1-8e73-483e-e053-2a95a90ac99b2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 0363-9992
AcetaminophenACETAMINOPHENWALGREENS CO.8dba6ae0-1bfb-84de-e053-2a95a90aae462025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 0363-9993
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Incf797848e-f23f-997b-e053-6394a90aae552025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENMAJOR PHARMACEUTICALSefd0a432-abbb-1f88-e053-2995a90a8ce52025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENLEADER/ Cardinal Health 110, Incf5dc335d-d3cf-ba94-e053-2a95a90ac6d32025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENSAM'S WEST INCe77c2bc7-0258-4a6d-e053-2a95a90afe6e2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 68196-935
AcetaminophenACETAMINOPHENCVS PHARMACY iNC90cea23f-5ddb-7a36-e053-2a95a90a20cf2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 69842-297

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 93 matching rows.

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