FDA.reportPublic FDA data

Application 207035

Type
ANDA
Sponsor
HERITAGE PHARMA

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
A207035-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31

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 UTC2022-10A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A207035-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2018-05-31a50c72e98297…

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 49 · 961 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
childrens fever reducer and pain relieverACETAMINOPHENRite Aid Corporation7f445de3-30cf-4bd8-892d-05979cd399e72026-09-09WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENWal-Mart Stores Inc78874258-16cc-40b5-9e15-5943eddfce942026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsName fallback
generic name: ACETAMINOPHEN
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsName fallback
generic name: ACETAMINOPHEN
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsName fallback
generic name: ACETAMINOPHEN
Feverall Jr. StrengthACETAMINOPHENSun Pharmaceutical Industries, Inc.3561bbc3-53b0-4857-8b71-39e165ed95ce2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsName fallback
generic name: ACETAMINOPHEN
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsName fallback
generic name: ACETAMINOPHEN
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsName fallback
generic name: ACETAMINOPHEN
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsName fallback
generic name: ACETAMINOPHEN
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsName fallback
generic name: ACETAMINOPHEN
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsName fallback
generic name: ACETAMINOPHEN
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsName fallback
generic name: ACETAMINOPHEN
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsName fallback
generic name: ACETAMINOPHEN
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Acetaminophen
generic name: ACETAMINOPHEN
major acetaminophenACETAMINOPHENMajor Pharmaceuticalsca9e1dae-eefb-4653-952f-2fde090596932026-08-27WarningsName fallback
generic name: ACETAMINOPHEN
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsName fallback
generic name: ACETAMINOPHEN

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 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11822-6690AcetaminophenAcetaminophenRite Aid CorporationANDACurrent
11822-6690AcetaminophenAcetaminophenRite Aid CorporationANDACurrent
23155-202AcetamiophenAcetaminophenHeritage Pharmaceuticals Inc.ANDACurrent
23155-202AcetamiophenAcetaminophenHeritage Pharmaceuticals Inc.ANDACurrent
23155-202AcetamiophenAcetaminophenHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-202AcetamiophenAcetaminophenHeritage Pharmaceuticals Inc.ANDACurrent
41163-669AcetaminophenAcetaminophenEQUALINE (SuperValu)ANDACurrent
41163-669AcetaminophenAcetaminophenEQUALINE (SuperValu)ANDACurrent
41163-669AcetaminophenAcetaminophenEQUALINE (SuperValu)ANDACurrent
41163-669AcetaminophenAcetaminophenEQUALINE (SuperValu)ANDACurrent
41163-669AcetaminophenAcetaminophenEQUALINE (SuperValu)ANDACurrent
59726-669ArthritisPain ReliefAcetaminophenP & L Development, LLCANDACurrent
59726-669ArthritisPain ReliefAcetaminophenP & L Development, LLCANDACurrent
59726-671Muscle Pain ReliefAcetaminophenP & L Development, LLCANDACurrent
69842-093AcetaminophenAcetaminophenCVS PharmacyANDACurrent
69842-093AcetaminophenAcetaminophenCVS PharmacyANDACurrent
69842-093AcetaminophenAcetaminophenCVS PharmacyANDACurrent
69842-093AcetaminophenAcetaminophenCVS PharmacyANDACurrent