FDA.reportPublic FDA data

Application 207229

Type
ANDA
Sponsor
AUROBINDO PHARMA 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
A207229-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09

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 UTC2022-10A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09a50c72e98297…

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENAurohealth LLCe072e4ab-669d-40ee-b301-0bc15b67792f2026-05-21WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 58602-848
AcetaminophenACETAMINOPHENBetter Living Brands, LLCde3d9840-4ada-5c9a-e053-2a95a90a57212026-04-21WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 21130-108
AcetaminophenACETAMINOPHENAmerican Health Packaging88e5345a-f240-473c-b329-2b0aa5f081f92026-02-04WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENKROGER COMPANYb9b63c38-83e7-62d2-e053-2a95a90a55262024-10-19WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 30142-157
AcetaminophenACETAMINOPHENBluePoint Laboratoriesc065c531-88f5-0930-e053-2a95a90ae8612024-06-05WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 68001-495
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113df1bc-a217-33ea-e063-6294a90a46432024-05-14WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENWALGREEN CO.c20d110a-ed5e-aed4-e053-2a95a90a42002024-05-06WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 0363-9604
AcetaminophenACETAMINOPHENAurohealth LLCf076fd33-9eaf-49b9-b0ee-6a349567c5ff2024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 58602-873
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.b70beee4-407e-547c-e053-2a95a90af22a2024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 69842-037
AcetaminophenACETAMINOPHENAurohealth LLC179c221d-c099-400c-b3ac-124e269476202024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 58602-730
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.e577fdf0-85b1-1471-e053-2995a90a6fcd2024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 69842-635
AcetaminophenACETAMINOPHENWALMART INC.0035a4fd-8dd5-4534-a1b5-f510d637f7212024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 79903-132

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 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9604AcetaminophenAcetaminophenWALGREEN CO.ANDACurrent
0363-9604AcetaminophenAcetaminophenWALGREEN CO.ANDACurrent
0363-9604AcetaminophenAcetaminophenWALGREEN CO.ANDACurrent
21130-108AcetaminophenAcetaminophenBetter Living Brands, LLCANDACurrent
30142-157AcetaminophenAcetaminophenKROGER COMPANYANDACurrent
30142-157AcetaminophenAcetaminophenKROGER COMPANYANDACurrent
58602-730AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-730AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-730AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-730AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-730AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-730AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-848AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-848AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-848AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-866AcetaminophenAcetaminophenAurohealth LLCANDACurrent
58602-873AcetaminophenAcetaminophenAurohealth LLCANDACurrent
68001-495AcetaminophenAcetaminophenBluePoint LaboratoriesANDACurrent
69842-037AcetaminophenAcetaminophenCVS Pharmacy, Inc.ANDACurrent
69842-037AcetaminophenAcetaminophenCVS Pharmacy, Inc.ANDACurrent
69842-037AcetaminophenAcetaminophenCVS Pharmacy, Inc.ANDACurrent
69842-635AcetaminophenAcetaminophenCVS Pharmacy, Inc.ANDACurrent
79903-132AcetaminophenAcetaminophenWALMART INC.ANDACurrent