FDA.reportPublic FDA data

Application 078569

Type
ANDA
Sponsor
SUN PHARM INDS 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
A078569-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14

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 UTC2022-10A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENCVS Pharmacy6f880abe-5284-42b0-9db6-b071444b197b2024-12-27WarningsExact identifier
application applno (ANDA): 078569
application number: ANDA078569
ndc (product): 69842-930
AcetaminophenACETAMINOPHENWalgreen Companya1cec332-5802-4684-8b7f-6cb98da40e8b2018-08-15WarningsExact identifier
application applno (ANDA): 078569
application number: ANDA078569
ndc (product): 0363-0340

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0340AcetaminophenAcetaminophenWalgreen CompanyANDACurrent
37205-662AcetaminophenAcetaminophenCardinal HealthANDACurrent
49035-350AcetaminophenAcetaminophenWal-Mart Stores, IncANDACurrent
51660-340AcetaminophenAcetaminophenOhm Laboratories Inc.ANDACurrent
59779-340ARTHRITIS PAIN RELIEFAcetaminophenCVS PHARMACYANDACurrent
59779-340ARTHRITIS PAIN RELIEFAcetaminophenCVS PHARMACYANDACurrent
68016-340Premier Value Arthritis Pain RelieverAcetaminophenChain Drug Consortium, LLCANDACurrent
69842-930AcetaminophenAcetaminophenCVS PharmacyANDACurrent
69842-930AcetaminophenAcetaminophenCVS PharmacyANDACurrent